Focused sterilization and sterilized sub-assemblies for analyte monitoring systems

ABSTRACT

A system includes a sensor applicator, a sensor control device arranged within the sensor applicator and including an electronics housing and a sensor extending from a bottom of the electronics housing, and a cap coupled to one of the sensor applicator and the sensor control device, wherein the cap is removable prior to deploying the sensor control device from the sensor applicator.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/112,700, filed Dec. 4, 2020, which is a continuation of InternationalPatent Application No. PCT/US2019/035810, filed Jun. 6, 2019, whichclaims the benefit of U.S. Provisional Patent Application No. 62/681,906filed Jun. 7, 2018, U.S. Provisional Patent Application No. 62/681,914filed Jun. 7, 2018, U.S. Provisional Patent Application No. 62/776,536filed Dec. 7, 2018, U.S. Provisional Patent Application No. 62/784,074filed Dec. 21, 2018, U.S. Provisional Patent Application No. 62/788,475filed Jan. 4, 2019, U.S. Provisional Patent Application No. 62/798,703filed Jan. 30, 2019, U.S. Provisional Patent Application No. 62/829,100filed Apr. 4, 2019, U.S. Provisional Patent Application No. 62/836,203filed Apr. 19, 2019, U.S. Provisional Patent Application No. 62/836,193filed Apr. 19, 2019, U.S. Provisional Patent Application No. 62/847,572filed May 14, 2019, and U.S. Provisional Patent Application No.62/849,442 filed May 17, 2019 which are hereby incorporated by referencein their entireties.

BACKGROUND

Diabetes is an incurable chronic disease in which the body does notproduce or properly utilize insulin, a hormone produced by the pancreasthat regulates blood glucose. When blood glucose levels rise, e.g.,after a meal, insulin lowers the blood glucose levels by moving theblood glucose from the blood and into the body cells. When the pancreasdoes not produce sufficient insulin (a condition known as Type IDiabetes) or the body does not properly utilize insulin (a conditionknown as Type II Diabetes), the blood glucose remains in the blood,which could result in hyperglycemia or abnormally high blood sugarlevels.

If symptoms of diabetes are not carefully monitored and treated,numerous complications can arise, including diabetic ketoacidosis,nonketotic hyperosmolar coma, cardiovascular disease, stroke, kidneyfailure, foot ulcers, eye damage, and nerve damage. Traditionally,monitoring has involved an individual pricking a finger to draw bloodand testing the blood for glucose levels. Advancements that are morerecent have allowed for continuous and long-term monitoring of bloodglucose using biological sensors that are maintained in contact withbodily fluids for periods of days, weeks, or longer.

Analyte monitoring systems, for example, have been developed tofacilitate long-term monitoring of bodily fluid analytes, such asglucose. Analyte monitoring systems typically include a sensorapplicator configured to place a biological sensor into contact with abodily fluid. More specifically, during delivery of the sensor to theskin of a user, at least a portion of the sensor is positioned below theskin surface, e.g., in the subcutaneous or dermal tissue.

It is important for devices implanted in the body or positioned belowthe skin to be sterile upon insertion. Sterilization can include anynumber of processes that effectively eliminate or kill transmissibleagents, such as bacteria, fungi, and viruses. These transmittableagents, if not eliminated from the device, may be substantiallydetrimental to the health and safety of the user.

Some but not all analyte monitoring systems might require separatesterilization processes to sterilize the sensor and the electroniccomponents. Electron beam sterilization, for example, is one example ofradiation sterilization that can be used to terminally sterilize thesensor. Radiation sterilization, however, can harm the electroniccomponents associated with the sensor. Consequently, the electroniccomponents are commonly sterilized via gaseous chemical sterilizationusing, for example, ethylene oxide. Ethylene oxide, however, can damagethe chemistry provided on the sensor. As such, integrating electronicsand the sensor into one unit can complicate the sterilization process.

These issues can be worked around by separating the components into asensor unit (e.g., a biological analyte sensor) and an adaptor unit(containing the data transmission electronics), so that each componentcan be packaged and sterilized separately using the appropriatesterilization method. This approach, however, requires additionalcomponents, additional packaging, additional process steps, and finaluser assembly of the two components, introducing a possibility of usererror. Thus, a need exists for analyte monitoring systems that may besterilized without separating the components.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures are included to illustrate certain aspects of thepresent disclosure, and should not be viewed as exclusive embodiments.The subject matter disclosed is capable of considerable modifications,alterations, combinations, and equivalents in form and function, withoutdeparting from the scope of this disclosure.

FIG. 1 is a conceptual diagram depicting an example analyte monitoringsystem that may incorporate one or more embodiments of the presentdisclosure.

FIGS. 2A-2G are progressive views of the assembly and application of thesystem of FIG. 1 incorporating a two-piece architecture.

FIGS. 3A and 3B are isometric and side views, respectively, of anexample sensor control device.

FIGS. 4A and 4B are isometric and exploded views, respectively, of theplug assembly of FIGS. 3A-3B.

FIGS. 5A and 5B are exploded and bottom isometric views, respectively,of the electronics housing of FIGS. 3A-3B.

FIGS. 6A and 6B are side and cross-sectional side views, respectively,of the sensor applicator of FIG. 1 with the cap of FIG. 2B coupledthereto.

FIG. 7A is an enlarged cross-sectional side view of the sensor controldevice of FIG. 6B mounted within the cap of FIG. 6B.

FIG. 7B is an enlarged cross-sectional side view of another embodimentof the sensor control device of FIG. 6B mounted within the sensorapplicator of FIG. 6B.

FIGS. 8-12 are schematic diagrams of example external sterilizationassemblies, according to one or more embodiments of the presentdisclosure.

FIG. 13 is an isometric view of an example sensor control device.

FIG. 14A is a side view of the sensor applicator of FIG. 1.

FIG. 14B is a cross-sectional side view of the sensor applicator of FIG.14A.

FIG. 15 is a cross-sectional side view of the sensor applicator of FIG.14A and another example embodiment of the external sterilizationassembly of FIG. 14B, according to one or additional more embodiments.

FIG. 16 is a cross-sectional side view of the sensor applicator of FIG.14A and another example embodiment of the external sterilizationassembly of FIG. 14B, according to one or more additional embodiments.

FIGS. 17A and 17B are isometric top and bottom views, respectively, ofone example of the external sterilization assembly of FIG. 14B,according to one or more embodiments.

FIG. 18 is an isometric view of an example sensor control device.

FIG. 19A is a side view of the sensor applicator of FIG. 1.

FIG. 19B is a partial cross-sectional side view of the sensor applicatorof FIG. 3A.

FIGS. 20A-20C are various views of the applicator insert of FIG. 19B,according to one or more embodiments of the disclosure.

FIG. 21 is another cross-sectional side view of the sensor applicator ofFIG. 19A showing a hybrid sterilization assembly, according to one ormore embodiments of the disclosure.

FIGS. 22A and 22B are isometric and cross-sectional side views,respectively, of another embodiment of the applicator insert of FIGS.20A-20C.

FIG. 23 is a diagram of an example analyte monitoring system that mayincorporate one or more embodiments of the present disclosure.

FIG. 24 is a schematic diagram of an example internal sterilizationassembly, according to one or more additional embodiments of the presentdisclosure.

FIG. 25 is a schematic diagram of another example internal sterilizationassembly, according to one or more additional embodiments of the presentdisclosure.

FIGS. 26A and 26B are isometric and side views, respectively, of anexample sensor control device.

FIGS. 27A and 27B are isometric and exploded views, respectively, of theplug assembly of FIGS. 26A-26B.

FIG. 27C is an exploded isometric bottom view of the plug and thepreservation vial.

FIGS. 28A and 28B are exploded and bottom isometric views, respectively,of the electronics housing of FIGS. 26A-26B.

FIGS. 29A and 29B are side and cross-sectional side views, respectively,of the sensor applicator of FIG. 1 with the cap of FIG. 2B coupledthereto.

FIG. 30 is a perspective view of an example embodiment of the cap ofFIGS. 29A-29B.

FIG. 31 is a cross-sectional side view of the sensor control devicepositioned within the cap.

FIGS. 32A and 32B are isometric and side views, respectively, of anexample sensor control device.

FIGS. 33A and 33B are exploded perspective top and bottom views,respectively, of the sensor control device of FIGS. 32A-32B.

FIGS. 34A and 34B are side and cross-sectional side views, respectively,of the sensor applicator of FIG. 1 with the cap of FIG. 2B coupledthereto.

FIG. 35 is an enlarged cross-sectional side view of the sensor controldevice mounted within the sensor applicator.

FIG. 36 is an enlarged cross-sectional bottom view of the sensor controldevice mounted atop the cap post.

FIGS. 37A-37C are isometric, side, and bottom views, respectively, of anexample sensor control device.

FIGS. 38A and 38B are isometric exploded top and bottom views,respectively, of the sensor control device of FIGS. 37A-37C.

FIGS. 39A-39D show example assembly of the sensor control device ofFIGS. 37A-37C.

FIGS. 40A and 40B are side and cross-sectional side views, respectively,of a sensor applicator with the pre-assembled sensor control device ofFIGS. 37A-37C arranged therein.

FIGS. 41A and 41B are enlarged cross-sectional views of the sensorcontrol device during example radiation sterilization.

FIG. 42 is a plot that graphically depicts approximate penetration depthas a function of e-beam energy level for a one-sided e-beamsterilization (or irradiation) process.

FIG. 43 is a cross-sectional side view of a sensor applicator with thepre-assembled sensor control device of FIGS. 37A-37C arranged therein,according to one or more additional embodiments.

FIG. 44 is a side view of an example sensor control device.

FIG. 45 is an exploded view of the sensor control device of FIG. 44.

FIG. 46A is a cross-sectional side view of the assembled sealedsubassembly of FIG. 45, according to one or more embodiments.

FIG. 46B is a cross-sectional side view of the fully assembled sensorcontrol device of FIG. 44.

FIGS. 47A and 47B are side and cross-sectional side views, respectively,of an example embodiment of the sensor applicator of FIG. 1 with the capof FIG. 2B coupled thereto.

FIG. 48 is a perspective view of an example embodiment of the cap ofFIGS. 47A-47B.

FIG. 49 is a cross-sectional side view of the sensor control devicepositioned within the cap of FIGS. 47A-47B.

FIGS. 50A and 50B are isometric and side views, respectively, of anotherexample sensor control device.

FIGS. 51A and 51B are exploded isometric top and bottom views,respectively of the sensor control device of FIGS. 50A-50B.

FIG. 52 is a cross-sectional side view of an assembled sealedsubassembly, according to one or more embodiments.

FIGS. 53A-53C are progressive cross-sectional side views showingassembly of the sensor applicator with the sensor control device ofFIGS. 50A-50B.

FIGS. 54A and 54B are perspective and top views, respectively, of thecap post of FIG. 53C, according to one or more additional embodiments.

FIG. 55 is a cross-sectional side view of the sensor control device ofFIGS. 50A-50B positioned within the cap of FIGS. 12B-12C.

FIGS. 56A and 56B are cross-sectional side views of the sensorapplicator ready to deploy the sensor control device to a targetmonitoring location.

FIGS. 57A-57C are progressive cross-sectional side views showingassembly and disassembly of an example embodiment of the sensorapplicator with the sensor control device of FIGS. 50A-50B.

FIG. 58A is an isometric bottom view of the housing, according to one ormore embodiments.

FIG. 58B is an isometric bottom view of the housing with the sheath andother components at least partially positioned therein.

FIG. 59 is an enlarged cross-sectional side view of the sensorapplicator with the sensor control device installed therein, accordingto one or more embodiments.

FIG. 60A is an isometric top view of the cap, according to one or moreembodiments.

FIG. 60B is an enlarged cross-sectional view of the engagement betweenthe cap and the housing, according to one or more embodiments.

FIGS. 61A and 61B are isometric views of the sensor cap and the collar,respectively, according to one or more embodiments.

FIG. 62 is an isometric top view of an example sensor control device,according to one or more embodiments of the present disclosure.

FIG. 63 is a schematic side view of an example sensor applicator,according to one or more embodiments of the present disclosure.

FIGS. 64A and 64B are exploded isometric views of the sensor applicatorand the sensor control device of FIGS. 62 and 63.

FIGS. 65A-65D are progressive cross-sectional side views of the sensorapplicator of FIGS. 63 and 64A-64B depicting example deployment of asensor control device, according to one or more embodiments.

FIG. 66 is an enlarged cross-sectional side view of an engagementbetween the sensor retainer and the sensor control device of FIGS.65A-65D, according to one or more embodiments.

FIG. 67 is an exploded isometric view of another sensor applicator withthe sensor control device of FIG. 62, according to one or moreadditional embodiments.

FIGS. 68A-68D are progressive cross-sectional side views of the sensorapplicator of FIG. 67 depicting example deployment of the sensor controldevice, according to one or more embodiments.

FIG. 69A is an enlarged schematic view of the sharp hub and the fingersof the sensor retainer.

FIGS. 69B and 69C are enlarged schematic views of the fingersinteracting with the upper portion of the needle shroud.

FIGS. 70A and 70B are enlarged cross-sectional side views of exampleengagement between the sensor retainer and the sensor control device,according to one or more embodiments.

FIGS. 71A and 71B are isometric and cross-sectional side views,respectively, of an example sensor retainer, according to one or moreembodiments of the present disclosure.

FIGS. 72A and 72B are enlarged cross-sectional side views of the sensorretainer of FIGS. 71A-71B retaining the sensor control device, accordingto one or more embodiments.

FIGS. 73A and 73B are side and cross-sectional side views, respectively,of an example sensor applicator, according to one or more embodiments.

FIGS. 74A and 74B are isometric top and bottom views, respectively, ofthe internal applicator cover of FIG. 73B.

FIG. 75 is an isometric view of an example embodiment of the sensor capof FIG. 73B, according to one or more embodiments.

FIG. 76 is an isometric, cross-sectional side view of the sensor cap ofFIG. 75 received by the internal applicator cover of FIGS. 74A-74B,according to one or more embodiments.

FIG. 77 shows progressive removal of the applicator cap of FIG. 73A andthe internal applicator cover of FIGS. 74A-74B from the sensorapplicator of FIGS. 73A-73B, according to one or more embodiments.

FIG. 78 is a schematic diagram of an example sensor applicator,according to one or more additional embodiments of the presentdisclosure.

FIG. 79 is an exploded view of an example sensor control device,according to one or more additional embodiments.

FIG. 80 is a bottom view of one embodiment of the sensor control deviceof FIG. 79.

FIGS. 81A and 81B are isometric and side views, respectively, of asensor control device in accordance with one or more embodiments of thepresent disclosure.

FIG. 82 is an exploded perspective top view of the sensor control deviceof FIG. 81A.

FIG. 83 is a cross-sectional side view in perspective of an examplesensor control device assembly including a sensor control device of FIG.81A mounted within the sensor applicator, the sensor control devicebeing compatible with the analyte monitoring system of FIG. 1.

FIG. 84 is an enlarged cross-sectional side view of the sensor controldevice assembly of FIG. 83.

FIG. 85 is a bottom view of a few members of the sensor control deviceassembly of FIG. 83, the members including the sensor control deviceheld in a sensor carrier of the sensor applicator.

FIG. 86 is a schematic diagram of an example sterilization assembly,according to one or more embodiments of the present disclosure.

FIG. 87 is a schematic diagram of another example sterilizationassembly, according to one or more embodiments of the presentdisclosure.

FIG. 88A is a schematic bottom view of another example sterilizationassembly, according to one or more embodiments of the presentdisclosure.

FIGS. 88B and 88C are schematic bottom views of alternative embodimentsof the sterilization assembly of FIG. 88A, according to one or moreadditional embodiments of the present disclosure.

FIG. 89 is an isometric schematic view of an example sensor controldevice, according to one or more embodiments.

FIG. 90 is a schematic diagram of another example sterilizationassembly, according to one or more embodiments.

FIGS. 91A and 91B are side and isometric views, respectively, of anexample sensor control device, according to one or more embodiments ofthe present disclosure.

FIGS. 92A and 92B are exploded, isometric top and bottom views,respectively, of the sensor control device of FIG. 2, according to oneor more embodiments.

FIG. 93 is a cross-sectional side view of the sensor control device ofFIGS. 91A-91B and 92A-92B, according to one or more embodiments.

FIG. 93A is an exploded isometric view of a portion of anotherembodiment of the sensor control device of FIGS. 91A-91B and 92A-92B.

FIG. 94A is an isometric bottom view of the mount of FIGS. 91A-91B and92A-92B.

FIG. 94B is an isometric top view of the sensor cap of FIGS. 91A-91B and92A-92B.

FIGS. 95A and 95B are side and cross-sectional side views, respectively,of an example sensor applicator, according to one or more embodiments.

FIGS. 96A and 96B are perspective and top views, respectively, of thecap post of FIG. 95B, according to one or more embodiments.

FIG. 97 is a cross-sectional side view of the sensor control devicepositioned within the applicator cap, according to one or moreembodiments.

FIG. 98 is a cross-sectional view of a sensor control device showingexample interaction between the sensor and the sharp.

FIG. 99 is a cross-sectional side view of an example analyte monitoringsystem enclosure used to house at least a portion of a sensor controldevice.

FIG. 100A is an enlarged cross-sectional side view of the interfacebetween the sensor applicator and the cap as indicated by the dashed boxof FIG. 99.

FIG. 100B is an enlarged cross-sectional side view of the interfacebetween the sensor applicator and the cap as indicated by the dashed boxof FIG. 99 during or after gaseous chemical sterilization.

FIG. 101 is a cross-sectional side view of another example analytemonitoring system enclosure used to house at least a portion of thesensor control device of FIG. 1.

FIGS. 102A-102C provide finite element analysis results corresponding tothe interface between the housing and the cap during example gaseouschemical sterilization.

FIG. 103 is an isometric view of an example sensor control device.

FIGS. 104A and 104B are exploded, isometric views of the sensor controldevice of FIG. 103, according to one or more embodiments.

FIG. 105 is a cross-sectional side view of the assembled sensor controldevice of FIGS. 104A-104B, according to one or more embodiments.

FIG. 106 is an isometric view of another example sensor control device.

FIGS. 107A and 107B are exploded, isometric views of the sensor controldevice of FIG. 106, according to one or more embodiments.

FIG. 108 is a cross-sectional side view of the assembled sensor controldevice of FIGS. 107A-107B, according to one or more embodiments.

FIG. 109 is an isometric view of an example converting process formanufacturing a sensor control device in accordance with the principlesof the present disclosure.

FIGS. 110A-110E depict progressive fabrication of the sensor controldevice of FIG. 109, according to one or more embodiments.

FIG. 111A is a top view of the sensor control device of FIG. 109 inpreparation for pressure testing and/or vacuum sealing, according to oneor more embodiments.

FIG. 111B is a cross-sectional side view of the sensor control device ofFIG. 109 with a compressor.

FIG. 112 is a partial cross-sectional side view of an example sensorcontrol device, according to one or more embodiments.

FIG. 113 is a cross-sectional side view of an example sensor applicator,according to one or more embodiments.

FIGS. 114A and 114B are top and bottom perspective views, respectively,of an example embodiment of the plug of FIGS. 27A-27B.

FIGS. 115A and 115B are perspective views depicting an exampleembodiment of the connector of FIGS. 27A-27B in open and closed states,respectively.

FIG. 116 is a perspective view of an example embodiment of the sensor ofFIGS. 27A-27B.

FIGS. 117A and 117B are bottom and top perspective views, respectively,depicting an example embodiment of a sensor module assembly.

FIGS. 118A and 118B are close-up partial views of an example embodimentof the sensor plug of FIGS. 114A-114B having certain axial stiffeningfeatures.

FIG. 119 is a side view of an example sensor, according to one or moreembodiments of the disclosure.

FIGS. 120A and 120B are isometric and partially exploded isometric viewsof an example connector assembly, according to one or more embodiments.

FIG. 120C is an isometric bottom view of the connector of FIGS.120A-120B.

FIGS. 121A and 121B are isometric and partially exploded isometric viewsof another example connector assembly, according to one or moreembodiments.

FIG. 121C is an isometric bottom view of the connector of FIGS.121A-121B.

DETAILED DESCRIPTION

The present application is generally related to systems, devices, andmethods for assembling an applicator and sensor control device for usein an in vivo analyte monitoring system.

FIG. 1 is a conceptual diagram depicting an example analyte monitoringsystem 100 that may incorporate one or more embodiments of the presentdisclosure. A variety of analytes can be detected and quantified usingthe system 100 (hereafter “the system 100”) including, but not limitedto, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones(e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, but not limited to, antibiotics(e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugsof abuse, theophylline, and warfarin, may also be determined.

As illustrated, the system 100 includes a sensor applicator 102(alternately referred to as an “inserter”), a sensor control device 104(also referred to as an “in vivo analyte sensor control device”), and areader device 106. The sensor applicator 102 is used to deliver thesensor control device 104 to a target monitoring location on a user'sskin (e.g., the arm of the user). Once delivered, the sensor controldevice 104 is maintained in position on the skin with an adhesive patch108 coupled to the bottom of the sensor control device 104. A portion ofa sensor 110 extends from the sensor control device 104 and ispositioned such that it can be transcutaneously positioned and otherwiseretained under the surface of the user's skin during the monitoringperiod.

An introducer may be included to promote introduction of the sensor 110into tissue. The introducer may comprise, for example, a needle oftenreferred to as a “sharp.” Alternatively, the introducer may compriseother types of devices, such as a sheath or a blade. The introducer maytransiently reside in proximity to the sensor 110 prior to tissueinsertion and then be withdrawn afterward. While present, the introducermay facilitate insertion of the sensor 110 into tissue by opening anaccess pathway for the sensor 110 to follow. For example, the introducermay penetrate the epidermis to provide an access pathway to the dermisto allow subcutaneous implantation of the sensor 110. After opening theaccess pathway, the introducer may be withdrawn (retracted) so that itdoes not represent a hazard while the sensor 110 remains in place. Inillustrative embodiments, the introducer may be solid or hollow, beveledor non-beveled, and/or circular or non-circular in cross-section. Inmore particular embodiments, suitable introducers may be comparable incross-sectional diameter and/or tip design to an acupuncture needle,which may have a cross-sectional diameter of about 250 microns. It is tobe recognized, however, that suitable introducers may have a larger orsmaller cross-sectional diameter if needed for particular applications.

In some embodiments, a tip of the introducer (while present) may beangled over the terminus of the sensor 110, such that the introducerpenetrates a tissue first and opens an access pathway for the sensor110. In other illustrative embodiments, the sensor 110 may reside withina lumen or groove of the introducer, with the introducer similarlyopening an access pathway for the sensor 110. In either case, theintroducer is subsequently withdrawn after facilitating sensor 110insertion. Moreover, the introducer (sharp) can be made of a variety ofmaterials, such as various types of metals and plastics.

When the sensor control device 104 is properly assembled, the sensor 110is placed in communication (e.g., electrical, mechanical, etc.) with oneor more electrical components or sensor electronics included within thesensor control device 104. In some applications, for example, the sensorcontrol device 104 may include a printed circuit board (PCB) having adata processor (e.g., an application specific integrated circuit orASIC) mounted thereto, and the sensor 110 may be operatively coupled tothe data processor which, in turn, may be coupled with an antenna and apower source.

The sensor control device 104 and the reader device 106 are configuredto communicate with one another over a local communication path or link112, which may be wired or wireless, uni- or bi-directional, andencrypted or non-encrypted. The reader device 106 may constitute anoutput medium for viewing analyte concentrations and alerts ornotifications determined by the sensor 110 or a processor associatedtherewith, as well as allowing for one or more user inputs, according tosome embodiments. The reader device 106 may be a multi-purposesmartphone or a dedicated electronic reader instrument. While only onereader device 106 is shown, multiple reader devices 106 may be presentin certain instances.

The reader device 106 may also be in communication with a remoteterminal 114 and/or a trusted computer system 116 via communicationpath(s)/link(s) 118 and/or 120, respectively, which also may be wired orwireless, uni- or bi-directional, and encrypted or non-encrypted. Thereader device 106 may also or alternately be in communication with anetwork 122 (e.g., a mobile telephone network, the internet, or a cloudserver) via communication path/link 124. The network 122 may be furthercommunicatively coupled to remote terminal 114 via communicationpath/link 126 and/or the trusted computer system 116 via communicationpath/link 128.

Alternately, the sensor control device 104 may communicate directly withthe remote terminal 114 and/or the trusted computer system 116 withoutan intervening reader device 106 being present. For example, the sensor110 may communicate with the remote terminal 114 and/or the trustedcomputer system 116 through a direct communication link to the network122, according to some embodiments, as described in U.S. Pat. No.10,136,816, incorporated herein by reference in its entirety.

Any suitable electronic communication protocol may be used for each ofthe communication paths or links, such as near field communication(NFC), radio frequency identification (RFID), BLUETOOTH® or BLUETOOTH®low energy protocols, WiFi, or the like. The remote terminal 114 and/orthe trusted computer system 116 may be accessible, according to someembodiments, by individuals other than a primary user who have aninterest in the user's analyte levels. The reader device 106 may includea display 130 and an optional input component 132. The display 130 maycomprise a touch-screen interface, according to some embodiments.

In some embodiments, the sensor control device 104 may automaticallyforward data to the reader device 106. For example, analyteconcentration data may be communicated automatically and periodically,such as at a certain frequency as data is obtained or after a certaintime period has passed, with the data being stored in a memory untiltransmittal (e.g., every minute, five minutes, or other predeterminedtime period). In other embodiments, the sensor control device 104 maycommunicate with the reader device 106 in a non-automatic manner and notaccording to a set schedule. For example, data may be communicated fromthe sensor control device 104 using RFID technology when the sensorelectronics are brought into communication range of the reader device106. Until communicated to the reader device 106, data may remain storedin a memory of the sensor control device 104. Thus, a patient does nothave to maintain close proximity to the reader device 106 at all times,and can instead upload data when convenient. In yet other embodiments, acombination of automatic and non-automatic data transfer may beimplemented. For example, data transfer may continue on an automaticbasis until the reader device 106 is no longer in communication range ofthe sensor control device 104.

The sensor control device 104 is often included with the sensorapplicator 104 in what is known as a “two-piece” architecture thatrequires final assembly by a user before the sensor 110 can be properlydelivered to the target monitoring location. More specifically, thesensor 110 and the associated electrical components included in thesensor control device 104 are provided to the user in multiple (two)packages, and the user must open the packaging and follow instructionsto manually assemble the components before delivering the sensor 110 tothe target monitoring location with the sensor applicator 102.

More recently, however, advanced designs of sensor control devices andsensor applicators have resulted in a one-piece architecture that allowsthe system to be shipped to the user in a single, sealed package thatdoes not require any final user assembly steps. Rather, the user needonly open one package and subsequently deliver the sensor control deviceto the target monitoring location. The one-piece system architecture mayprove advantageous in eliminating component parts, various fabricationprocess steps, and user assembly steps. As a result, packaging and wasteare reduced, and the potential for user error or contamination to thesystem is mitigated.

In the illustrated embodiment, the system 100 may comprise what is knownas a “two-piece” architecture that requires final assembly by a userbefore the sensor 110 can be properly delivered to the target monitoringlocation. More specifically, the sensor 110 and the associatedelectrical components included in the sensor control device 104 areprovided to the user in multiple (two) packages, where each may or maynot be sealed with a sterile barrier but are at least enclosed inpackaging. The user must open the packaging and follow instructions tomanually assemble the components and subsequently deliver the sensor 110to the target monitoring location with the sensor applicator 102.

FIGS. 2A-2G are progressive views of the assembly and application of thesystem 100 incorporating a two-piece architecture. FIGS. 2A and 2Bdepict the first and second packages, respectively, provided to the userfor final assembly. More specifically, FIG. 2A depicts a sensorcontainer or tray 202 that has a removable lid 204. The user preparesthe sensor tray 202 by removing the lid 204, which acts as a sterilebarrier to protect the internal contents of the sensor tray 202 andotherwise maintain a sterile internal environment. Removing the lid 204exposes a platform 206 positioned within the sensor tray 202, and a plugassembly 207 (partially visible) is arranged within and otherwisestrategically embedded within the platform 206. The plug assembly 207includes a sensor module (not shown) and a sharp module (not shown). Thesensor module carries the sensor 110 (FIG. 1), and the sharp modulecarries an associated sharp used to help deliver the sensor 110transcutaneously under the user's skin during application of the sensorcontrol device 104 (FIG. 1).

FIG. 2B depicts the sensor applicator 102 and the user preparing thesensor applicator 102 for final assembly. The sensor applicator 102includes a housing 208 sealed at one end with an applicator cap 210. Insome embodiments, for example, an O-ring or another type of sealinggasket may seal an interface between the housing 208 and the applicatorcap 210. In at least one embodiment, the O-ring or sealing gasket may bemolded onto one of the housing 208 and the applicator cap 210. Theapplicator cap 210 provides a barrier that protects the internalcontents of the sensor applicator 102. In particular, the sensorapplicator 102 contains an electronics housing (not shown) that retainsthe electrical components for the sensor control device 104 (FIG. 1),and the applicator cap 210 may or may not maintain a sterile environmentfor the electrical components. Preparation of the sensor applicator 102includes uncoupling the housing 208 from the applicator cap 210, whichcan be accomplished by unscrewing the applicator cap 210 from thehousing 208. The applicator cap 210 can then be discarded or otherwiseplaced aside.

FIG. 2C depicts the user inserting the sensor applicator 102 into thesensor tray 202. The sensor applicator 102 includes a sheath 212configured to be received by the platform 206 to temporarily unlock thesheath 212 relative to the housing 208, and also temporarily unlock theplatform 206 relative to the sensor tray 202. Advancing the housing 208into the sensor tray 202 results in the plug assembly 207 (FIG. 2A)arranged within the sensor tray 202, including the sensor and sharpmodules, being coupled to the electronics housing arranged within thesensor applicator 102.

In FIG. 2D, the user removes the sensor applicator 102 from the sensortray 202 by proximally retracting the housing 208 with respect to thesensor tray 202.

FIG. 2E depicts the bottom or interior of the sensor applicator 102following removal from the sensor tray 202 (FIG. 2). The sensorapplicator 102 is removed from the sensor tray 202 with the sensorcontrol device 104 fully assembled therein and positioned for deliveryto the target monitoring location. As illustrated, a sharp 220 extendsfrom the bottom of the sensor control device 104 and carries a portionof the sensor 110 within a hollow or recessed portion thereof. The sharp220 is configured to penetrate the skin of a user and thereby place thesensor 110 into contact with bodily fluid.

FIGS. 2F and 2G depict example delivery of the sensor control device 104to a target monitoring location 222, such as the back of an arm of theuser. FIG. 2F shows the user advancing the sensor applicator 102 towardthe target monitoring location 222. Upon engaging the skin at the targetmonitoring location 222, the sheath 212 collapses into the housing 208,which allows the sensor control device 104 (FIGS. 2E and 2G) to advanceinto engagement with the skin. With the help of the sharp 220 (FIG. 2E),the sensor 110 (FIG. 2E) is advanced transcutaneously into the patient'sskin at the target monitoring location 222.

FIG. 2G shows the user retracting the sensor applicator 102 from thetarget monitoring location, with the sensor control device 104successfully attached to the user's skin. The adhesive patch 108(FIG. 1) applied to the bottom of sensor control device 104 adheres tothe skin to secure the sensor control device 104 in place. The sharp 220(FIG. 2E) is automatically retracted when the housing 208 is fullyadvanced at the target monitoring location 222, while the sensor 110(FIG. 2E) is left in position to measure analyte levels.

For the two-piece architecture system, the sensor tray 202 (FIG. 2A) andthe sensor applicator 102 (FIG. 2B) are provided to the user as separatepackages, thus requiring the user to open each package and finallyassemble the system. In some applications, the discrete, sealed packagesallow the sensor tray 202 and the sensor applicator 102 to be sterilizedin separate sterilization processes unique to the contents of eachpackage and otherwise incompatible with the contents of the other.

More specifically, the sensor tray 202, which includes the plug assembly207 (FIG. 2A), including the sensor 110 (FIGS. 1 and 2E) and the sharp220 (FIG. 2E), may be sterilized using radiation sterilization, such aselectron beam (or “e-beam”) irradiation. Radiation sterilization,however, can damage the electrical components arranged within theelectronics housing of the sensor control device 104. Consequently, ifthe sensor applicator 102, which contains the electronics housing of thesensor control device 104, needs to be sterilized, it may be sterilizedvia another method, such as gaseous chemical sterilization using, forexample, ethylene oxide. Gaseous chemical sterilization, however, candamage the enzymes or other chemistry and biologics included on thesensor 110. Because of this sterilization incompatibility, the sensortray 202 and the sensor applicator 102 may be sterilized in separatesterilization processes and subsequently packaged separately, andthereby requiring the user to finally assemble the components uponreceipt.

According to embodiments of the present disclosure, the system 100(FIG. 1) may comprise a one-piece architecture that incorporatessterilization techniques specifically designed for a one-piecearchitecture. The one-piece architecture allows the system 100 to beshipped to the user in a single, sealed package that does not requireany final user assembly steps. Rather, the user need only open onepackage and subsequently deliver the sensor control device to the targetmonitoring location, as generally described above with reference toFIGS. 2E-2G. The one-piece system architecture described herein mayprove advantageous in eliminating component parts, various fabricationprocess steps, and user assembly steps. As a result, packaging and wasteare reduced, and the potential for user error or contamination to thesystem is mitigated.

Focused Electron Beam Sterilization with Collimator

FIGS. 3A and 3B are isometric and side views, respectively, of anexample sensor control device 302, according to one or more embodimentsof the present disclosure. The sensor control device 302 (alternatelyreferred to as a “puck”) may be similar in some respects to the sensorcontrol device 104 of FIG. 1 and therefore may be best understood withreference thereto. The sensor control device 302 may replace the sensorcontrol device 104 of FIG. 1 and, therefore, may be used in conjunctionwith the sensor applicator 102 (FIG. 1), which delivers the sensorcontrol device 302 to a target monitoring location on a user's skin.

The sensor control device 302, however, may be incorporated into aone-piece system architecture. Unlike the two-piece architecture system,for example, a user is not required to open multiple packages andfinally assemble the sensor control device 302. Rather, upon receipt bythe user, the sensor control device 302 is already fully assembled andproperly positioned within the sensor applicator 102. To use the sensorcontrol device 302, the user need only break one barrier (e.g., theapplicator cap 210 of FIG. 2B) before promptly delivering the sensorcontrol device 302 to the target monitoring location.

As illustrated, the sensor control device 302 includes an electronicshousing 304 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing304 may exhibit other cross-sectional shapes, such as ovoid (e.g.,pill-shaped), a squircle, or polygonal, without departing from the scopeof the disclosure. The electronics housing 304 may be configured tohouse or otherwise contain various electrical components used to operatethe sensor control device 302.

The electronics housing 304 may include a shell 306 and a mount 308 thatis matable with the shell 306. The shell 306 may be secured to the mount308 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, or one or more mechanical fasteners(e.g., screws). In some cases, the shell 306 may be secured to the mount308 such that a sealed interface therebetween is generated. In suchembodiments, a gasket or other type of seal material may be positionedat or near the outer diameter (periphery) of the shell 306 and the mount308, and securing the two components together may compress the gasketand thereby generate a sealed interface. In other embodiments, anadhesive may be applied to the outer diameter (periphery) of one or bothof the shell 306 and the mount 308. The adhesive secures the shell 306to the mount 308 and provides structural integrity, but may also sealthe interface between the two components and thereby isolate theinterior of the electronics housing 304 from outside contamination. Ifthe sensor control device 302 is assembled in a controlled environment,there may be no need to terminally sterilize the internal electricalcomponents. Rather, the adhesive coupling may provide a sufficientsterile barrier for the assembled electronics housing 304.

The sensor control device 302 may further include a plug assembly 310that may be coupled to the electronics housing 304. The plug assembly310 may be similar in some respects*to the plug assembly 207 of FIG. 2A.For example, the plug assembly 310 may include a sensor module 312(partially visible) interconnectable with a sharp module 314 (partiallyvisible). The sensor module 312 may be configured to carry and otherwiseinclude a sensor 316 (partially visible), and the sharp module 314 maybe configured to carry and otherwise include a sharp 318 (partiallyvisible) used to help deliver the sensor 316 transcutaneously under auser's skin during application of the sensor control device 302. Asillustrated, corresponding portions of the sensor 316 and the sharp 318extend from the electronics housing 304 and, more particularly, from thebottom of the mount 308. The exposed portion of the sensor 316 may bereceived within a hollow or recessed portion of the sharp 318. Theremaining portion of the sensor 316 is positioned within the interior ofthe electronics housing 304.

FIGS. 4A and 4B are isometric and exploded views, respectively, of theplug assembly 310, according to one or more embodiments. The sensormodule 312 may include the sensor 316, a plug 402, and a connector 404.The plug 402 may be designed to receive and support both the sensor 316and the connector 404. As illustrated, a channel 406 may be definedthrough the plug 402 to receive a portion of the sensor 316. Moreover,the plug 402 may provide one or more deflectable arms 407 configured tosnap into corresponding features provided on the bottom of theelectronics housing 304 (FIGS. 3A-3B).

The sensor 316 includes a tail 408, a flag 410, and a neck 412 thatinterconnects the tail 408 and the flag 410. The tail 408 may beconfigured to extend at least partially through the channel 406 andextend distally from the plug 402. The tail 408 includes an enzyme orother chemistry or biologic and, in some embodiments, a membrane maycover the chemistry. In use, the tail 408 is transcutaneously receivedbeneath a user's skin, and the chemistry included thereon helpsfacilitate analyte monitoring in the presence of bodily fluids.

The flag 410 may comprise a generally planar surface having one or moresensor contacts 414 (three shown in FIG. 4B) arranged thereon. Thesensor contact(s) 414 may be configured to align with a correspondingnumber of compliant carbon impregnated polymer modules (not shown)encapsulated within the connector 404.

The connector 404 includes one or more hinges 418 that enables theconnector 404 to move between open and closed states. The connector 404is depicted in FIGS. 4A-4B in the closed state, but can pivot to theopen state to receive the flag 410 and the compliant carbon impregnatedpolymer module(s) therein. The compliant carbon impregnated polymermodule(s) provide electrical contacts 420 (three shown) configured toprovide conductive communication between the sensor 316 andcorresponding circuitry contacts provided within the electronics housing304 (FIGS. 3A-3B). The connector 404 can be made of silicone rubber andmay serve as a moisture barrier for the sensor 316 when assembled in acompressed state and after application to a user's skin.

The sharp module 314 includes the sharp 318 and a sharp hub 422 thatcarries the sharp 318. The sharp 318 includes an elongate shaft 424 anda sharp tip 426 at the distal end of the shaft 424. The shaft 424 may beconfigured to extend through the channel 406 and extend distally fromthe plug 402. Moreover, the shaft 424 may include a hollow or recessedportion 428 that at least partially circumscribes the tail 408 of thesensor 316. The sharp tip 426 may be configured to penetrate the skinwhile carrying the tail 408 to put the active chemistry present on thetail 408 into contact with bodily fluids.

The sharp hub 422 may include a hub small cylinder 430 and a hub snappawl 432, each of which may be configured to help couple the plugassembly 310 (and the entire sensor control device 302) to the sensorapplicator 102 (FIG. 1).

FIGS. 5A and 5B are exploded and bottom isometric views, respectively,of the electronics housing 304, according to one or more embodiments.The shell 306 and the mount 308 operate as opposing clamshell halvesthat enclose or otherwise substantially encapsulate the variouselectronic components of the sensor control device 302 (FIGS. 3A-3B).

A printed circuit board (PCB) 502 may be positioned within theelectronics housing 304. A plurality of electronic modules (not shown)may be mounted to the PCB 502 including, but not limited to, a dataprocessing unit, resistors, transistors, capacitors, inductors, diodes,and switches. The data processing unit may comprise, for example, anapplication specific integrated circuit (ASIC) configured to implementone or more functions or routines associated with operation of thesensor control device 302. More specifically, the data processing unitmay be configured to perform data processing functions, where suchfunctions may include but are not limited to, filtering and encoding ofdata signals, each of which corresponds to a sampled analyte level ofthe user. The data processing unit may also include or otherwisecommunicate with an antenna for communicating with the reader device 106(FIG. 1).

As illustrated, the shell 306, the mount 308, and the PCB 502 eachdefine corresponding central apertures 504, 506, and 508, respectively.When the electronics housing 304 is assembled, the central apertures504, 506, and 508 coaxially align to receive the plug assembly 310(FIGS. 4A-4B) therethrough. A battery 510 may also be housed within theelectronics housing 304 and configured to power the sensor controldevice 302.

In FIG. 5B, a plug receptacle 512 may be defined in the bottom of themount 308 and provide a location where the plug assembly 310 (FIGS.4A-4B) may be received and coupled to the electronics housing 304, andthereby fully assemble the sensor control device 302 (FIG. 3A-3B). Theprofile of the plug 402 (FIGS. 4A-4B) may match or be shaped incomplementary fashion to the plug receptacle 512, and the plugreceptacle 512 may provide one or more snap ledges 514 (two shown)configured to interface with and receive the deflectable arms 407 (FIGS.4A-4B) of the plug 402. The plug assembly 310 is coupled to theelectronics housing 304 by advancing the plug 402 into the plugreceptacle 512 and allowing the deflectable arms 407 to lock into thecorresponding snap ledges 514. When the plug assembly 310 (FIGS. 4A-4B)is properly coupled to the electronics housing 304, one or morecircuitry contacts 516 (three shown) defined on the underside of the PCB502 may make conductive communication with the electrical contacts 420(FIGS. 4A-4B) of the connector 404 (FIGS. 4A-4B).

FIGS. 6A and 6B are side and cross-sectional side views, respectively,of the sensor applicator 102 with the applicator cap 210 coupledthereto. More specifically, FIGS. 6A-6B depict how the sensor applicator102 might be shipped to and received by a user, according to at leastone embodiment. In some embodiments, however, the sensor applicator 102might further be sealed within a bag (not shown) and delivered to theuser within the bag. The bag may be made of a variety of materials thathelp prevent the ingress of humidity into the sensor applicator 102,which might adversely affect the sensor 316. In at least one embodiment,for example, the sealed back might be made of foil. Any and all of thesensor applicators described or discussed herein may be sealed withinand delivered to the user within the bag.

According to the present disclosure, and as seen in FIG. 6B, the sensorcontrol device 302 is already assembled and installed within the sensorapplicator 102 prior to being delivered to the user. The applicator cap210 may be threaded to the housing 208 and include a tamper ring 602.Upon rotating (e.g., unscrewing) the applicator cap 210 relative to thehousing 208, the tamper ring 602 may shear and thereby free theapplicator cap 210 from the sensor applicator 102. Following which, theuser may deliver the sensor control device 302 to the target monitoringlocation, as generally described above with reference to FIGS. 2E-2G.

In some embodiments, as mentioned above, the applicator cap 210 may besecured to the housing 208 via a sealed engagement to protect theinternal components of the sensor applicator 102. In at least oneembodiment, for example, an O-ring or another type of sealing gasket mayseal an interface between the housing 208 and the applicator cap 210.The O-ring or sealing gasket may be a separate component part oralternatively molded onto one of the housing 208 and the applicator cap210.

The housing 208 may be made of a variety of rigid materials. In someembodiments, for example, the housing 208 may be made of a thermoplasticpolymer, such as polyketone. In other embodiments, the housing 208 maybe made of cyclic olefin copolymer (COC), which can help preventmoisture ingress into the interior of the sensor applicator 102. As willbe appreciated, any and all of the housings described or discussedherein may be made of polyketone or COC.

With specific reference to FIG. 6B, the sensor control device 302 may beloaded into the sensor applicator 102 by mating the sharp hub 422 with asensor carrier 604 included within the sensor applicator 102. Once thesensor control device 302 is mated with the sensor carrier 604, theapplicator cap 210 may then be secured to the sensor applicator 102.

In the illustrated embodiment, a collimator 606 is positioned within theapplicator cap 210 and may generally help support the sensor controldevice 302 while contained within the sensor applicator 102. In someembodiments, the collimator 606 may form an integral part or extensionof the applicator cap 210, such as being molded with or overmolded ontothe applicator cap 210. In other embodiments, the collimator 606 maycomprise a separate structure fitted within or attached to theapplicator cap 210, without departing from the scope of the disclosure.In yet other embodiments, as discussed below, the collimator 606 may beomitted in the package received by the user, but otherwise used whilesterilizing and preparing the sensor applicator 102 for delivery.

The collimator 606 may be designed to receive and help protect parts ofthe sensor control device 302 that need to be sterile, and isolate thesterile components of the sensor applicator 102 from microbialcontamination from other locations within the sensor control device 302.To accomplish this, the collimator 606 may define or otherwise provide asterilization zone 608 (alternately referred to as a “sterile barrierenclosure” or a “sterile sensor path”) configured to receive the sensor316 and the sharp 318 as extending from the bottom of the electronicshousing 304. The sterilization zone 608 may generally comprise a hole orpassageway extending at least partially through the body of thecollimator 606. In the illustrated embodiment, the sterilization zone608 extends through the entire body of the collimator 606, but mayalternatively extend only partially therethrough, without departing fromthe scope of the disclosure.

When the sensor control device 302 is loaded into the sensor applicator102 and the applicator cap 210 with the collimator 606 is securedthereto, the sensor 316 and the sharp 318 may be positioned within asealed region 610 at least partially defined by the sterilization zone608. The sealed region 610 is configured to isolate the sensor 316 andthe sharp 318 from external contamination and may include (encompass)select portions of the interior of the electronics housing 304 and thesterilization zone 608 of the collimator 606.

While positioned within the sensor applicator 102, the fully assembledsensor control device 302 may be subjected to radiation sterilization612. The radiation sterilization 612 may comprise, for example, e-beamirradiation, but other methods of sterilization may alternatively beused including, but not limited to, low energy X-ray irradiation. Insome embodiments, the radiation sterilization 612 may be deliveredeither through continuous processing irradiation or through pulsed beamirradiation. In pulsed beam irradiation, the beam of radiationsterilization 612 is focused at a target location and the component partor device to be sterilized is moved to the target location at whichpoint the radiation sterilization 612 is activated to provide a directedpulse of radiation. The radiation sterilization 612 is then turned off,and another component part or device to be sterilized is moved to thetarget location and the process is repeated.

The collimator 606 may be configured to focus the radiation (e.g.,beams, waves, energy, etc.) from the radiation sterilization 612 towardthe components that are required to be sterile, such as the sensor 316and the sharp 318. More specifically, the hole or passageway of thesterilization zone 608 allows transmission of the radiation to impingeupon and sterilize the sensor 316 and the sharp 318, while the remainingportions of the collimator 606 prevent (impede) the propagatingradiation from disrupting or damaging the electronic components withinthe electronics housing 304.

The sterilization zone 608 can exhibit any suitable cross-sectionalshape necessary to properly focus the radiation on the sensor 316 andthe sharp 318 for sterilization. In the illustrated embodiment, forexample, the sterilization zone 608 is circular cylindrical, but couldalternatively exhibit a polygonal cross-sectional shape, such as cubicor rectangular (e.g., including parallelogram), without departing fromthe scope of the disclosure.

In the illustrated embodiment, the sterilization zone 608 provides afirst aperture 614 a at a first end and a second aperture 614 b at asecond end opposite the first end. The first aperture 614 a may beconfigured to receive the sensor 316 and the sharp 318 into thesterilization zone 608, and the second aperture 614 b may allow theradiation (e.g., beams, waves, etc.) from the radiation sterilization612 to enter the sterilization zone 608 and impinge upon the sensor 316and the sharp 318. In the illustrated embodiment, the first and secondapertures 614 a,b exhibit identical diameters.

The body of the collimator 606 reduces or eliminates the radiationsterilization 612 from penetrating through the body material and therebydamaging the electronic components within the electronics housing 304.To accomplish this, in some embodiments, the collimator 606 may be madeof a material that has a mass density greater than 0.9 grams per cubiccentimeter (g/cc). One example material for the collimator 606 ispolyethylene, but could alternatively comprise any material having amass density similar to or greater than polyethylene. In someembodiments, for example, the material for the collimator 606 maycomprise, but is not limited to, a metal (e.g., lead, stainless steel)or a high-density polymer.

In at least one embodiment, the design of the collimator 606 may bealtered so that the collimator 606 may be made of a material that has amass density less than 0.9 grams per cubic centimeter (g/cc) but stilloperate to reduce or eliminate the radiation sterilization 612 fromimpinging upon the electronic components within the electronics housing304. To accomplish this, in some embodiments, the size (e.g., length) ofthe collimator 606 may be increased such that the propagating electronsfrom the radiation sterilization 612 are required to pass through alarger amount of material before potentially impinging upon sensitiveelectronics. The larger amount of material may help absorb or dissipatethe dose strength of the radiation sterilization 612 such that itbecomes harmless to the sensitive electronics. In other embodiments,however, the converse may equally be true. More specifically, the size(e.g., length) of the collimator 606 may be decreased as long as thematerial for the collimator 606 exhibits a large enough mass density.

In addition to the radiation blocking characteristics of the body of thecollimator 606, in some embodiments, one or more shields 616 (one shown)may be positioned within the sensor housing 304 to protect sensitiveelectronic components from radiation while the sensor control device 302is subjected to the radiation sterilization 612. The shield 616, forexample, may be positioned to interpose a data processing unit 618 andthe radiation source (e.g., an e-beam electron accelerator). In suchembodiments, the shield 616 may be positioned adjacent to and otherwisealigned with the data processing unit 618 and the radiation source toblock or mitigate radiation exposure (e.g., e-beam radiation or energy)that might otherwise damage the sensitive electronic circuitry of thedata processing unit 618.

The shield 616 may be made of any material capable of blocking (orsubstantially blocking) the transmission of radiation. Suitablematerials for the shield 616 include, but are not limited to, lead,tungsten, iron-based metals (e.g., stainless steel), copper, tantalum,tungsten, osmium, or any combination thereof. Suitable metals may becorrosion-resistant, austenitic, and any non-magnetic metal with adensity ranging between about 5 grams per cubic centimeter (g/cc) andabout 15 g/cc. The shield 616 may be fabricated via a variety ofmanufacturing techniques including, but not limited to, stamping,casting, injection molding, sintering, two-shot molding, or anycombination thereof.

In other embodiments, however, the shield 616 may comprise ametal-filled thermoplastic polymer such as, but not limited to,polyamide, polycarbonate, or polystyrene. In such embodiments, theshield 616 may be fabricated by mixing the shielding material in anadhesive matrix and dispensing the combination onto shaped components orotherwise directly onto the data processing unit 618. Moreover, in suchembodiments, the shield 616 may comprise an enclosure that encapsulates(or substantially encapsulates) the data processing unit 618.

In some embodiments, a collimator seal 620 may be applied to the end ofthe collimator 606 to seal off the sterilization zone 608 and, thus, thesealed region 610. As illustrated, the collimator seal 620 may seal thesecond aperture 614 b. The collimator seal 620 may be applied before orafter the radiation sterilization 612. In embodiments where thecollimator seal 620 is applied before undertaking the radiationsterilization 612, the collimator seal 620 may be made of a radiationpermeable microbial barrier material that allows radiation to propagatetherethrough. With the collimator seal 620 in place, the sealed region610 is able to maintain a sterile environment for the assembled sensorcontrol device 302 until the user removes (unthreads) the applicator cap210.

In some embodiments, the collimator seal 620 may comprise two or morelayers of different materials. The first layer may be made of asynthetic material (e.g., a flash-spun high-density polyethylene fiber),such as Tyvek® available from DuPont®. Tyvek® is highly durable andpuncture resistant and allows the permeation of vapors. The Tyvek® layercan be applied before or after the radiation sterilization 612, andfollowing the radiation sterilization 612, a foil or other vapor andmoisture resistant material layer may be sealed (e.g., heat sealed) overthe Tyvek® layer to prevent the ingress of contaminants and moistureinto the sterilization zone 608 and the sealed region 610. In otherembodiments, the collimator seal 620 may comprise only a singleprotective layer applied to the end of the collimator 606. In suchembodiments, the single layer is gas permeable for the sterilizationprocess, but is also capable of protection against moisture and otherharmful elements once the sterilization process is complete.Accordingly, the collimator seal 620 may operate as a moisture andcontaminant layer, without departing from the scope of the disclosure.

It is noted that, while the sensor 316 and the sharp 318 extend from thebottom of the electronics housing 304 and into the sterilization zone608 generally concentric with a centerline of the sensor applicator 102and the applicator cap 210, it is contemplated herein to have aneccentric arrangement. More specifically, in at least one embodiment,the sensor 316 and the sharp 318 may extend from the bottom of theelectronics housing 304 eccentric to the centerline of the sensorapplicator 102 and the applicator cap 210. In such embodiments, thecollimator 606 may be re-designed and otherwise configured such that thesterilization zone 608 is also eccentrically positioned to receive thesensor 316 and the sharp 318, without departing from the scope of thedisclosure.

In some embodiments, the collimator 606 may comprise a first or“internal” collimator capable of being housed within the applicator cap210 or otherwise within the sensor applicator 102, as generallydescribed above. A second or “external” collimator (not shown) may alsobe included or otherwise used in the assembly (manufacturing) process tohelp sterilize the sensor applicator 102. In such embodiments, theexternal collimator may be positioned external to the sensor applicator102 and the applicator cap 210 and used simultaneously with the internalcollimator 606 to help focus the radiation sterilization 612 on thesensor 316 and the sharp 318.

In one embodiment, for example, the external collimator may initiallyreceive the radiation sterilization 612. Similar to the internalcollimator 606, the external collimator may provide or define a hole orpassageway extending through the external collimator. The beams of theradiation sterilization 612 passing through the passageway of theexternal collimator may be focused and received into the sterilizationzone 608 of the internal collimator 606 via the second aperture 614 b.Accordingly, the external collimator may operate to pre-focus theradiation energy, and the internal collimator 606 may fully focus theradiation energy on the sensor 316 and the sharp 318.

In some embodiments, the internal collimator 606 may be omitted if theexternal collimator is capable of properly and fully focusing theradiation sterilization 612 to properly sterilize the sensor 316 and thesharp 318. In such embodiments, the sensor applicator may be positionedadjacent the external collimator and subsequently subjected to theradiation sterilization 612, and the external collimator may preventradiation energy from damaging the sensitive electronics within theelectronics housing 304. Moreover, in such embodiments, the sensorapplicator 102 may be delivered to the user without the internalcollimator 606 positioned within the applicator cap 210, thuseliminating complexity in manufacturing and use.

FIG. 7A is an enlarged cross-sectional side view of the sensor controldevice 302 mounted within the applicator cap 210, according to one ormore embodiments. As indicated above, portions of the sensor 316 and thesharp 318 may be arranged within the sealed region 610 and therebyisolated from external contamination. The sealed region 610 may include(encompass) select portions of the interior of the electronics housing304 and the sterilization zone 608 of the collimator 606. In one or moreembodiments, the sealed region 610 may be defined and otherwise formedby at least a first seal 702 a, a second seal 702 b, and the collimatorseal 620.

The first seal 702 a may be arranged to seal the interface between thesharp hub 422 and the top of the electronics housing 304. Moreparticularly, the first seal 702 a may seal the interface between thesharp hub 422 and the shell 306. Moreover, the first seal 702 a maycircumscribe the first central aperture 504 defined in the shell 306such that contaminants are prevented from migrating into the interior ofthe electronics housing 304 via the first central aperture 504. In someembodiments, the first seal 702 a may form part of the sharp hub 422.For example, the first seal 702 a may be overmolded onto the sharp hub422. In other embodiments, the first seal 702 a may be overmolded ontothe top surface of the shell 306. In yet other embodiments, the firstseal 702 a may comprise a separate structure, such as an O-ring or thelike, that interposes the sharp hub 422 and the top surface of the shell306, without departing from the scope of the disclosure.

The second seal 702 b may be arranged to seal the interface between thecollimator 606 and the bottom of electronics housing 304. Moreparticularly, the second seal 702 b may be arranged to seal theinterface between the mount 308 and the collimator 606 or,alternatively, between the collimator 606 and the bottom of the plug 402as received within the bottom of the mount 308. In applicationsincluding the plug 402, as illustrated, the second seal 702 b may beconfigured to seal about and otherwise circumscribe the plug receptacle512. In embodiments that omit the plug 402, the second seal 702 b mayalternatively circumscribe the second central aperture 506 (FIG. 5A)defined in the mount 308. Consequently, the second seal 702 b mayprevent contaminants from migrating into the sterilization zone 608 ofthe collimator 606 and also from migrating into the interior of theelectronics housing 304 via the plug receptacle 512 (or alternativelythe second central aperture 506).

In some embodiments, the second seal 702 b may form part of thecollimator 606. For example, the second seal 702 b may be overmoldedonto the top of the collimator 606. In other embodiments, the secondseal 702 b may be overmolded onto the plug 402 or the bottom of themount 308. In yet other embodiments, the second seal 702 b may comprisea separate structure, such as an O-ring or the like, that interposes thecollimator 606 and the plug 402 or the bottom of the mount 308, withoutdeparting from the scope of the disclosure.

Upon loading the sensor control device 302 into the sensor applicator102 (FIG. 6B) and securing the applicator cap 210 to the sensorapplicator 102, the first and second seals 702 a,b become compressed andgenerate corresponding sealed interfaces. The first and second seals 702a,b may be made of a variety of materials capable of generating a sealedinterface between opposing structures. Suitable materials include, butare not limited to, silicone, a thermoplastic elastomer (TPE),polytetrafluoroethylene (PTFE or Teflon®), or any combination thereof.

As discussed above, the collimator seal 620 may be configured to sealoff the bottom of the sterilization zone 608 and, thus, the bottom ofthe sealed region 610. Accordingly, the first and second seals 702 a,band the collimator seal 620 each create corresponding barriers at theirrespective sealing locations. The combination of these seals 702 a,b and620 allows the sealed region 610 containing the sensor 316 and the sharp318 to be terminally sterilized.

FIG. 7B is an enlarged cross-sectional side view of another embodimentof the sensor control device 302 mounted within the sensor applicator102, according to one or more embodiments. More specifically, FIG. 7Bdepicts alternative embodiments of the first and second seals 702 a,b.The first seal 702 a is again arranged to seal the interface between thesharp hub 422 and the top of the electronics housing 304 and, moreparticularly, seal off the first central aperture 504 defined in theshell 306. In the illustrated embodiment, however, the first seal 702 amay be configured to seal both axially and radially. More particularly,when the sensor control device 302 is introduced into the sensorapplicator 102, the sharp hub 422 is received by the sensor carrier 604.The first seal 702 a may be configured to simultaneously bias againstone or more axially extending members 704 of the sensor carrier 604 andone or more radially extending members 706 of the sensor carrier 604.Such dual biased engagement compresses the first seal 702 a both axiallyand radially and thereby allows the first seal 702 a to seal against thetop of the electronics housing 304 in both the radial and axialdirections.

The second seal 702 b is again arranged to seal the interface betweenthe collimator 606 and the bottom of electronics housing 304 and, moreparticularly, between the mount 308 and the collimator 606 or,alternatively, between the collimator 606 and the bottom of the plug 402as received within the bottom of the mount 308. In the illustratedembodiment, however, the second seal 702 b may extend into thesterilization zone 608 and define or otherwise provide a cylindricalwell 708 sized to receive the sensor 316 and the sharp 1408 as extendingfrom the bottom of the mount 308. In some embodiments, a desiccant 710may be positioned within the cylindrical well to aid maintenance of alow humidity environment for biological components sensitive tomoisture.

In some embodiments, the second seal 702 b may be omitted and thecollimator 606 may be directly coupled to the electronics housing 304.More specifically, in at least one embodiment, the collimator 606 may bethreadably coupled to the underside of the mount 308. In suchembodiments, the collimator 606 may provide or otherwise define athreaded extension configured to mate with a threaded aperture definedin the bottom of the mount 308. Threadably coupling the collimator 606to the mount 308 may seal the interface between the collimator 606 andthe bottom of electronics housing 304, and thus operate to isolatesealed region 610. Moreover, in such embodiments, the pitch and gauge ofthe threads defined on the collimator 606 and the mount 308 may matchthose of the threaded engagement between the applicator cap 210 and thesensor applicator 102. As a result, as the applicator cap 210 isthreaded to or unthreaded from the sensor applicator 102, the collimator606 may correspondingly be threaded to or unthreaded from theelectronics housing 404.

Embodiments disclosed herein include:

A. An analyte monitoring system that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing, a sensor extending from a bottom ofthe electronics housing, a sharp hub positioned adjacent a top of theelectronics housing, and a sharp carried by the sharp hub and extendingthrough the electronics housing and from the bottom of the electronicshousing. The analyte monitoring system further including a cap coupledto the sensor applicator, and a collimator positioned within the cap anddefining a sterilization zone that receives the sensor and the sharpextending from the bottom of the electronics housing.

B. A method of preparing an analyte monitoring system includes loading asensor control device into a sensor applicator, the sensor controldevice including an electronics housing, a sensor extending from abottom of the electronics housing, a sharp hub positioned adjacent a topof the electronics housing, and a sharp carried by the sharp hub andextending through the electronics housing and from the bottom of theelectronics housing. The method further including securing a cap to thesensor applicator, wherein a collimator is arranged within the cap anddefines a sterilization zone that receives the sensor and the sharpextending from the bottom of the electronics housing, sterilizing thesensor and the sharp with radiation sterilization while positionedwithin the sterilization zone, and preventing radiation from theradiation sterilization from damaging electronic components within theelectronics housing with the collimator.

C. A method of preparing an analyte monitoring system includes loading asensor control device into a sensor applicator, the sensor controldevice including an electronics housing, a sensor extending from abottom of the electronics housing, a sharp hub positioned adjacent a topof the electronics housing, and a sharp carried by the sharp hub andextending through the electronics housing and from the bottom of theelectronics housing. The method further including positioning the sensorapplicator adjacent a collimator, subjecting the sensor and the sharp toradiation sterilization, and preventing radiation from the radiationsterilization from damaging the electronic components within theelectronics housing with the collimator.

Each of embodiments A, B, and C may have one or more of the followingadditional elements in any combination: Element 1: wherein thesterilization zone comprises a passageway extending at least partiallythrough the collimator. Element 2: wherein the sterilization zonecomprises a cross-sectional shape selected from the group consisting ofcubic, rectangular, and any combination thereof. Element 3: wherein thesterilization zone defines a first aperture at a first end and a secondaperture at a second end, and wherein the first aperture receives thesensor and the sharp extending from the bottom of the electronicshousing and a seal is arranged at the second aperture. Element 4:further comprising a sealed region encompassing the sterilization zoneand a portion of an interior of the electronics housing, wherein thesealed region is defined by a first seal that seals an interface betweenthe sharp hub and the top of the electronics housing, a second seal thatseals an interface between the collimator and the bottom of theelectronics housing, and a third seal that seals an end of thesterilization zone. Element 5: wherein the first seal circumscribes acentral aperture defined in the top of the electronics housing andprevents contaminants from migrating into the portion of the interior ofthe electronics housing via the central aperture, and wherein the secondseal circumscribes an aperture defined in the bottom of the electronicshousing and prevents contaminants from migrating into the portion of theinterior of the electronics housing via the aperture. Element 6: whereinthe first seal provides one or both of an axial and a radial seal.Element 7: wherein the second seal extends into the sterilization zoneand defines a cylindrical well that receives the sensor and the sharp.Element 8: further comprising a printed circuit board arranged withinthe electronics housing, a data processing unit mounted to the printedcircuit board, and a shield positioned within the electronics housing toprotect the data processing unit from radiation from a radiationsterilization process. Element 9: wherein the shield is made of anon-magnetic metal selected from the group consisting of lead, tungsten,iron, stainless steel, copper, tantalum, osmium, a thermoplastic polymermixed with a non-magnetic metal, and any combination thereof.

Element 10: further comprising creating a sealed region as the cap issecured to the sensor applicator, the sealed region encompassing thesterilization zone and a portion of an interior of the electronicshousing. Element 11: wherein creating the sealed region comprisessealing an interface between the sharp hub and the top of theelectronics housing with a first seal, sealing an interface between thecollimator and the bottom of the electronics housing with a second seal,and sealing an end of the sterilization zone with a third seal. Element12: wherein sealing the interface between the sharp hub and the top ofthe electronics housing with the first seal comprises providing one orboth of an axial seal and a radial seal with the first seal. Element 13:wherein the collimator comprises an internal collimator and sterilizingthe sensor and the sharp with the radiation sterilization furthercomprises positioning the sensor applicator adjacent an externalcollimator arranged external to the sensor applicator, focusing theradiation with the external collimator to be received by the internalcollimator, and preventing the radiation from damaging the electroniccomponents within the electronics housing with the external and internalcollimators. Element 14: wherein the sterilization zone defines a firstaperture at a first end of the collimator and a second aperture at asecond end of the collimator, and wherein sterilizing the sensor and thesharp comprises introducing radiation into the sterilization zone viathe second aperture. Element 15: wherein preventing the radiation fromthe radiation sterilization from damaging the electronic componentscomprises blocking the radiation with the material of the collimator.Element 16: wherein a printed circuit board is arranged within theelectronics housing and a data processing unit is mounted to the printedcircuit board, the method further comprising protecting the dataprocessing unit from radiation from the radiation sterilization processwith a shield positioned within the electronics housing.

Element 17: wherein positioning the sensor applicator adjacent thecollimator comprises arranging the collimator such that it residesexternal to the sensor applicator during the radiation sterilization.

By way of non-limiting example, exemplary combinations applicable to A,B, and C include: Element 2 with Element 3; Element 4 with Element 5;Element 4 with Element 6; Element 4 with Element 7; Element 8 withElement 9; Element 10 with Element 11; and Element 11 with Element 12.

External Sterilization Assemblies

Referring again briefly to FIG. 1, prior to being delivered to an enduser, the sensor control device 104 must be sterilized to render theproduct free from viable microorganisms. The sensor 110 is commonlysterilized using radiation sterilization, such as electron beam(“e-beam”) irradiation. Radiation sterilization, however, can damage theelectronic components within the sensor control device 104, which arecommonly sterilized via gaseous chemical sterilization (e.g., usingethylene oxide). Gaseous chemical sterilization, however, can damage theenzymes or other chemistry and biologics included on the sensor 110.

In the past, this sterilization incompatibility has been circumvented byseparating the sensor 110 and the electronic components and sterilizingeach individually. This approach, however, requires additional parts,packaging, process steps, and final assembly by the user, whichintroduces a possibility of user error. According to the presentdisclosure, the sensor control device 104, or any device requiringterminal sterilization, may be properly sterilized using an externalsterilization assembly designed to focus sterilizing radiation (e.g.,beams, waves, energy, etc.) toward component parts requiringsterilization, while simultaneously preventing the propagating radiationfrom disrupting or damaging sensitive electronic components.

FIG. 8 is a schematic diagram of an example external sterilizationassembly 800, according to one or more embodiments of the presentdisclosure. The external sterilization assembly 800 (hereafter the“assembly 800”) may be designed and otherwise configured to helpsterilize a medical device 802. The medical device 802 may comprise, forexample, a sensor control device similar in some respects to the sensorcontrol device 104 of FIG. 1, but could alternatively comprise othertypes of medical devices, health care products, or systems requiringterminal sterilization of specific component parts. Example medicaldevices or health care products that may incorporate the principles ofthe present disclosure include, but are not limited to, ingestibleproducts, cardiac rhythm management (CRM) devices, under-skin sensingdevices, externally mounted medical devices, or any combination thereof.

The medical device 802 may include a housing 804, a part 806 requiringsterilization, and one or more radiation sensitive components 808. Inthe illustrated embodiment, the radiation sensitive component 808 may bemounted to a printed circuit board (PCB) 810 positioned within thehousing 804, and the housing 804 may comprise an electronics housing fora sensor control device. The radiation sensitive component 808 mayinclude one or more electronic modules such as, but not limited to, adata processing unit (e.g., an application specific integrated circuitor ASIC), a resistor, a transistor, a capacitor, an inductor, a diode,and a switch. In other embodiments, however, the radiation sensitivecomponent 808 may comprise a radiation sensitive chemical solution oranalyte, as described herein with reference to FIG. 12.

In some embodiments, the part 806 may comprise a sensor (e.g., thesensor 110 of FIG. 1) that extends from the housing 804. As illustrated,the part 806 may extend at an angle from the bottom of the housing 804,but could alternatively extend perpendicular to the bottom or fromanother surface of the housing 804. In at least one embodiment, the part806 may further include a sharp that may also require sterilization andmay help implant the sensor beneath the skin of a user. In someembodiments, as illustrated, the part 806 may be encapsulated with a cap812 that provides a sealed barrier that protects exposed portions of thepart 806 (e.g., the sensor and associated sharp) until the part 806 isneeded for use.

The medical device 802 may be subjected to radiation sterilization 814to properly sterilize the part 806 for use. Suitable radiationsterilization 814 processes include, but are not limited to, electronbeam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, orany combination thereof. In embodiments that include the cap 812, thecap 812 may be made of a material that permits propagation of theradiation 814 therethrough to facilitate radiation sterilization of thepart 806. Suitable materials for the cap 812 include, but are notlimited to, a non-magnetic metal (e.g., aluminum, copper, gold, silver,etc.), a thermoplastic, ceramic, rubber (e.g., ebonite), a compositematerial (e.g., fiberglass, carbon fiber reinforced polymer, etc.), anepoxy, or any combination thereof. In some embodiments, the cap 812 maybe transparent or translucent, but can otherwise be opaque, withoutdeparting from the scope of the disclosure.

The assembly 800 may include a radiation shield 816 positioned externalto the medical device 802 and configured to help sterilize the part 806while preventing (impeding) propagating radiation 814 from disrupting ordamaging the radiation sensitive component(s) 808. To accomplish this,the radiation shield 816 may provide a collimator 818 that generallycomprises a hole or passageway extending at least partially through thebody of the radiation shield 816. The collimator 818 defines asterilization zone 820 configured to focus the radiation 814 toward thepart 806. In the illustrated embodiment, the part 806 may also bereceived within the sterilization zone 820 for sterilization.

While focusing the radiation 814 (e.g., beams, waves, energy, etc.)toward the part 806, the radiation shield 816 may be made of a materialthat reduces or eliminates the radiation 814 from penetratingtherethrough and thereby damaging the radiation sensitive component(s)808 within the housing 804. In other words, the radiation shield 816 maybe made of a material having a density sufficient to absorb the dose ofthe beam energy being delivered. In some embodiments, for example, theradiation shield 816 may be made of any material that has a mass densitygreater than 0.9 grams per cubic centimeter (g/cc). In otherembodiments, however, the mass density of a suitable material may beless than 0.9 g/cc, without departing from the scope of the disclosure.Suitable materials for the radiation shield 816 include, but are notlimited to, a high-density polymer, (e.g., polyethylene, polypropylene,polystyrene, polytetrafluoroethylene, etc.), a metal (e.g., lead,stainless steel, aluminum, etc.), any combination thereof, or anymaterial having a mass density greater than 0.9 g/cc.

The collimator 818 can exhibit any suitable cross-sectional shapenecessary to focus the radiation on the part 806 for sterilization. Inthe illustrated embodiment, for example, the collimator 818 is conicalor frustoconical in shape. In other embodiments, however, the collimator818 may exhibit a polygonal cross-sectional shape, such as cubic,rectangular (e.g., including parallelogram), or pyramidal, withoutdeparting from the scope of the disclosure. In yet other embodiments,the collimator 818 may exhibit a circular cross-sectional shape withparallel sides.

In the illustrated embodiment, the collimator 818 provides a firstaperture 822 a and a second aperture 822 b where the first and secondapertures 822 a,b are defined at opposing ends of the sterilization zone820. The first aperture 822 a may allow the radiation 814 to enter thesterilization zone 820 and impinge upon the part 806, and the secondaperture 822 b may be configured to receive the part 806 into thesterilization zone 820. In embodiments where the collimator 818 isconical or frustoconcial in shape, the second aperture 822 b may have adiameter that is smaller than the diameter of the first aperture 822 a.In such embodiments, for example, the size of the second aperture 822 bmay range between about 0.5 mm and about 3.0 mm, and the size of thefirst aperture 822 a may range between about 5.0 mm and about 16.0 mm.As will be appreciated, however, the respective diameters of the firstand second apertures 822 a,b may be greater or less than the rangesprovided herein, without departing from the scope of the disclosure.Indeed, the diameters of the first and second apertures 822 a,b may bescaled to the device size and need only be large enough to allow asufficient dose of radiation to impinge upon the part 806. Moreover, inat least one embodiment, the collimator 818 may be cylindrical in shapewhere the first and second apertures 822 a,b exhibit identicaldiameters.

In some embodiments, the assembly 800 may further include a barriershield 824 positioned within the housing 804. The barrier shield 824 maybe configured to help block radiation 814 (e.g., electrons) frompropagating within the housing 804 toward the radiation sensitivecomponent(s) 808. The barrier shield 824 may be made of any of thematerials mentioned above for the radiation shield 816. In theillustrated embodiment, the barrier shield 824 is positioned verticallywithin the housing 804, but may alternatively be positioned at any otherangular configuration suitable for protecting the radiation sensitivecomponent(s) 808.

FIG. 9 is a schematic diagram of another example external sterilizationassembly 900, according to one or more additional embodiments of thepresent disclosure. The external sterilization assembly 900 (hereafterthe “assembly 900”) may be similar in some respects to the assembly 800of FIG. 8 and therefore may be best understood with reference thereto,where like numerals will refer to similar components not describedagain. Similar to the assembly 800, the assembly 900 may be designed andotherwise configured to help sterilize a medical device 902. In theillustrated embodiment, the medical device 902 may comprise a two-piecesensor control device, but could alternatively comprise any of themedical devices mentioned herein with respect to the medical device 802.

As illustrated, the medical device 902 includes a housing 904, a part906 requiring sterilization, and one or more radiation sensitivecomponents 908 positioned within the housing 904. The housing 904 maycomprise packaging or an enclosure that contains the part 906 and theradiation sensitive component(s) 908. The radiation sensitivecomponent(s) 908 may comprise any of the electronic modules mentionedherein with respect to the radiation sensitive component(s) 808 of FIG.8. The part 906 may comprise, for example a needle/sensor subassembly,and may be subjected to radiation sterilization 814 to properlysterilize the part 906 for use.

The assembly 900 may include a radiation shield 910 positioned externalto the medical device 902 and configured to help sterilize the part 906while preventing (impeding) propagating radiation 814 from damaging theradiation sensitive component(s) 908. In the illustrated embodiment, theradiation shield 910 may define or otherwise provide an internal cavity912 into which the medical device 902 may be positioned. Similar to theradiation shield 816 of FIG. 8, the radiation shield 910 may provide acollimator 914 that generally comprises a hole or passageway extendingat least partially through the body of the radiation shield 910 andproviding access into the cavity 912. The collimator 914 may define asterilization zone 916 that helps focus the radiation 814 toward thepart 906. The radiation shield 910 may be made of any of the materialsmentioned above with respect to the radiation shield 816 to reduce oreliminate the radiation 814 from penetrating therethrough, except for atthe collimator 914, and thereby damaging the radiation sensitivecomponent(s) 908 within the housing 904.

To properly sterilize the part 906, the radiation sterilization 814 maybe directed at the medical device 902. The collimator 914 andsterilization zone 916 may be configured to concentrate and/or focus theradiation sterilization 814 toward the part 906, while the remainingportions of the radiation shield 910 prevent (impede) the propagatingradiation 814 from damaging the radiation sensitive component(s) 908within the housing 904. In the illustrated embodiment, the collimator914 and sterilization zone 916 exhibit a circular cross-sectional shapewith parallel sides, but could alternatively exhibit othercross-sectional shapes including, but not limited to, conical,frustoconical, pyramidal, polygonal, or any combination thereof.

In some embodiments, the assembly 900 may further include the barriershield 824 positioned within the housing 904 to help block radiation 814(e.g., electrons) from propagating within the housing 904 toward theradiation sensitive component(s) 908.

FIG. 10 is a schematic diagram of another example external sterilizationassembly 1000, according to one or more additional embodiments of thepresent disclosure. The external sterilization assembly 1000 (hereafterthe “assembly 1000”) may be similar in some respects to the assembly 900of FIG. 15 and therefore may be best understood with reference thereto,where like numerals will refer to similar components not describedagain. Similar to the assembly 900, the assembly 1000 may be designedand otherwise configured to help sterilize a medical device 1002. In theillustrated embodiment, the medical device 1002 may comprise a sensorcontrol device similar to the sensor control device 104 of FIG. 1, butcould alternatively comprise any of the medical devices mentioned hereinwith respect to the medical device 802 of FIG. 8.

As illustrated, the medical device 1002 includes a housing 1004, a part1006 requiring sterilization, and one or more radiation sensitivecomponents 1008 positioned within the housing 1004. In the illustratedembodiment, the housing 1004 may comprise an electronics housing for asensor control device (e.g., the sensor control device 104 of FIG. 1)and the radiation sensitive component(s) 1008 may comprise any of theelectronic modules mentioned herein with respect to the radiationsensitive component(s) 808 of FIG. 8. In some embodiments, the part 1006may comprise a sensor (e.g., the sensor 110 of FIG. 1) that extends fromthe housing 1004, and may further include a sharp also requiringsterilization and used to help implant the sensor beneath the skin of auser.

The assembly 1000 may include a radiation shield 1010 positionedexternal to the medical device 1002 and configured to help sterilize thepart 1006 while preventing (impeding) propagating radiation 814 fromdisrupting or damaging the radiation sensitive component(s) 1008. Theradiation shield 1010 may be made of any of the materials mentionedabove with respect to the radiation shield 816 of FIG. 8 to reduce oreliminate the radiation 814 from penetrating therethrough and therebydamaging the radiation sensitive component(s) 1008 within the housing1004.

In the illustrated embodiment, the radiation shield 1010 may define orotherwise provide an internal cavity 1012 into which the medical device1002 may be positioned for sterilization. In some embodiments, theradiation shield 1010 may comprise a box and the internal cavity 1012may be formed within the interior of the box. The radiation shield 1010may also provide a collimator 1014 that extends at least partiallythrough the body of the radiation shield 1010 and provides access intothe cavity 1012. The collimator 1014 may define a sterilization zone1016 that focuses the radiation 814 toward the part 1006 forsterilization.

To properly sterilize the part 1006, the radiation sterilization 814 maybe directed at the medical device 1002. The collimator 1014 and thesterilization zone 1016 may concentrate and/or focus the radiationsterilization 814 toward the part 1006, while the remaining portions ofthe radiation shield 1010 prevent (impede) the propagating radiation 814from damaging the radiation sensitive component(s) 1008 within thehousing 1004. In the illustrated embodiment, the collimator 1014exhibits a circular cross-sectional shape with parallel sides, but couldalternatively exhibit other cross-sectional shapes including, but notlimited to, conical, frustoconical, pyramidal, polygonal, or anycombination thereof.

FIG. 11 is a schematic diagram of another example external sterilizationassembly 1100, according to one or more additional embodiments of thepresent disclosure. The external sterilization assembly 1100 (hereafterthe “assembly 1100”) may be similar in some respects to the assemblies800, 900, and 1000 of FIGS. 8, 9, and 10, respectively, and thereforemay be best understood with reference thereto. Similar to the assemblies800-1000, the assembly 1100 may be designed and otherwise configured tohelp sterilize a medical device 1102. In the illustrated embodiment, themedical device 1102 may comprise a two piece sensor control device, butcould alternatively comprise any of the medical devices mentioned hereinwith respect to the medical device 802.

As illustrated, the medical device 1102 includes a housing 1104, a part1106 requiring sterilization, and one or more radiation sensitivecomponents 1108 positioned within the housing 1104. The radiationsensitive component(s) 1108 may comprise any of the electronic modulesmentioned herein with respect to the radiation sensitive component(s)808 of FIG. 8. In the illustrated embodiment, the part 1106 maycomprise, for example, a needle/sensor subassembly, and may be subjectedto radiation sterilization 814 to properly sterilize the part 1106 foruse.

The assembly 1100 may include a radiation shield 1110 positionedexternal to the medical device 1102 and configured to help sterilize thepart 1106 while preventing (impeding) propagating radiation 814 fromdamaging the radiation sensitive component(s) 1108. The radiation shield1110 may be made of any of the materials mentioned above with respect tothe radiation shield 816 of FIG. 8 to reduce or eliminate the radiation814 from penetrating therethrough and thereby damaging the radiationsensitive component(s) 1108.

In the illustrated embodiment, the radiation shield 1110 may comprise aclamshell structure including a first portion 1112 a and a secondportion 1112 b matable (or engageable) with the first portion 1112 a.The radiation shield 1110 may also provide or otherwise define aninternal cavity 1114 into which the medical device 1102 may bepositioned for sterilization. In some embodiments, as illustrated, thefirst and second portions 1112 a,b may cooperatively define a portion ofthe internal cavity 1114 such that when the first and second portions1112 a,b are properly mated, the internal cavity 1114 is formed. Inother embodiments, however, the internal cavity 1114 may be definedwholly within the first portion 1112 a or wholly within the secondportion 1112 b.

In some embodiments, the assembly 1100 may further include an absorber1116 configured to protect the medical device 1102. In at least oneembodiment, as illustrated, portions of the absorber 1116 may beprovided by or otherwise form part of each of the first and secondportions 1112 a,b. In such embodiments, the internal cavity 1114 may bedefined, at least in part by the absorber 1116. The absorber 1116 may bemade of a material that absorbs stray radiation without causingBremsstrahlung protons being generated. The material for the absorber1116 may comprise, for example, any of the high-density polymersmentioned herein for the radiation shield 816 of FIG. 8.

Similar to the radiation shield 816 of FIG. 8, the radiation shield 1110may provide a collimator. In the illustrated embodiment, however, theradiation shield 1110 provides or otherwise defines a first collimator1118 a and a second collimator 1118 b, but could alternatively includeonly one of the collimators 1118 a,b, without departing from the scopeof the disclosure. The first collimator 1118 a generally comprises ahole or passageway extending at least partially through the firstportion 1112 a of the radiation shield 1110, and the second collimator1118 b generally comprises a hole or passageway extending at leastpartially through the second portion 1112 b. Each collimator 1118 a,bprovides access into the internal cavity 1114 and the collimators 1118a,b cooperatively define a sterilization zone 1120 that includes theinternal cavity 1114 and helps focus the radiation 814 toward the part1106 for sterilization.

To properly sterilize the part 1106, the medical device 1102 may bepositioned within the internal cavity 1114 and the opposing portions1112 a,b may be mated to encapsulate the medical device 1102. Themedical device 1102 may be situated within the sterilization zone 1120once properly positioned within the cavity 1114. The radiationsterilization 814 may then be directed at the medical device 1102 onopposing sides of the radiation shield 1110, and the collimators 1118a,b may concentrate and/or focus the radiation sterilization 814 towardthe part 1106 on opposing sides of the part 1106. The remaining portionsof the radiation shield 1110 prevent (impede) the propagating radiation814 from damaging the radiation sensitive component(s) 1108 within thehousing 1104. In the illustrated embodiment, each collimator 1118 a,bexhibits a conical or frustoconical cross-sectional shape, but couldalternatively exhibit other cross-sectional shapes including, but notlimited to, circular, pyramidal, polygonal, or any combination thereof.

In some embodiments, the assembly 1100 may further include one or morebarrier shields 824 (two shown) positioned within the housing 1104 tohelp block radiation 814 (e.g., electrons) from propagating within thehousing 1104 toward the radiation sensitive component(s) 1108.

FIG. 12 is a schematic diagram of another example external sterilizationassembly 1200, according to one or more additional embodiments of thepresent disclosure. The external sterilization assembly 1200 (hereafterthe “assembly 1200”) may be designed and otherwise configured to helpsterilize a medical device 1202, which, in the illustrated embodiment,comprises a hypodermic needle or syringe. As illustrated, the medicaldevice 1202 includes a housing 1204 (e.g., a barrel or vial), a part1206 requiring sterilization, and one or more radiation sensitivecomponents 1208 positioned within the housing 1204. In the illustratedembodiment, the radiation sensitive component 1208 may comprise achemical solution or an analyte (e.g., an active agent, pharmaceutical,biologic, etc.) that may be sensitive to irradiation, and the part 1206may comprise a needle designed to deliver the chemical solution.

In some embodiments, as illustrated, the part 1206 may be encased orotherwise surrounded by a cap 1210 (e.g., a needle cap) thatencapsulates the part 1206. Moreover, in at least one embodiment, thecap 1210 may be sealed against the housing 1204 with a sealing element1212, such as an O-ring or the like. The cap 1210 and the sealingelement 1212 may cooperatively provide a sterile barrier system thatsurrounds and protects exposed portions of the part 1206 until requiredto be used. The part 1206 may be subjected to radiation sterilization814 to properly sterilize the part 1206 for use.

The assembly 1200 may include a radiation shield 1214 positionedexternal to the medical device 1202 and configured to help sterilize thepart 1206 while preventing (impeding) propagating radiation 814 fromdamaging the radiation sensitive component 1208. As illustrated, theradiation shield 1214 may provide a collimator 1216 that generallycomprises a hole or passageway extending at least partially through thebody of the radiation shield 1214 and defines a sterilization zone 1218configured to focus the radiation 814 toward the part 1206 forsterilization. In the illustrated embodiment, the part 1206 may also bereceived within the sterilization zone 1218. The collimator 1216 allowstransmission of the radiation 814 to impinge upon and sterilize the part1206, while the remaining portions of the radiation shield 1214 prevent(impede) the propagating radiation 814 from damaging the radiationsensitive component(s) 1208 within the housing 1204. In the illustratedembodiment, the collimator 1216 is conical or frustoconical in shape,but may alternatively exhibit other cross-sectional shapes, such aspolygonal, pyramidal, circular, or any combination thereof.

In embodiments including the cap 1210, the body of the cap 1210 maycomprise a material that permits propagation of radiation 814therethrough to facilitate radiation sterilization of the part 1206.Suitable materials for the cap 1210 may be the same as mentioned hereinfor the cap 812 of FIG. 8.

In some embodiments, the assembly 1200 may further include the barriershield 824 positioned to help block radiation 814 (e.g., electrons) frompropagating within the housing 1204 toward the radiation sensitivecomponent 1208 (e.g., the chemical solution). In the illustratedembodiment, the barrier shield 824 may define or otherwise provide acentral aperture 1220 configured to allow the radiation sensitivecomponent 1208 to exit the housing 1204 via the part 1206 (e.g., theneedle). In other embodiments, the barrier shield 824 may provide atortuous pathway that allows the radiation sensitive component 1208 toexit the housing 1204 via the part 1206.

FIG. 13 is an isometric view of an example sensor control device 1302,according to one or more additional embodiments of the presentdisclosure. The sensor control device 1302 may be the same as or similarto the sensor control device 104 of FIG. 1 and, therefore, may be usedin conjunction with the sensor applicator 102 (FIG. 1), which deliversthe sensor control device 1302 to a target monitoring location on auser's skin. Moreover, the sensor control device 1302 may be alternatelycharacterized as a medical device, similar to one or more of the medicaldevices 1402-1202 of FIGS. 8-12 described herein. Accordingly, thesensor control device 1302 may also require proper sterilization priorto being used.

As illustrated, the sensor control device 1302 includes an electronicshousing 1304 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing1304 may exhibit other cross-sectional shapes, such as ovoid (e.g.,pill-shaped), a squircle, or polygonal, without departing from the scopeof the disclosure. The electronics housing 1304 may be configured tohouse or otherwise contain various electronic components used to operatethe sensor control device 1302.

The electronics housing 1304 may include a shell 1306 and a mount 1308that is matable with the shell 1306. The shell 1306 may be secured tothe mount 1308 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, one or more mechanical fasteners (e.g.,screws), or any combination thereof. In some cases, the shell 1306 maybe secured to the mount 1308 such that a sealed interface therebetweenis generated. In such embodiments, a gasket or other type of sealmaterial may be positioned at or near the outer diameter (periphery) ofthe shell 1306 and the mount 1308, and securing the two componentstogether may compress the gasket and thereby generate a sealedinterface. In other embodiments, an adhesive may be applied to the outerdiameter (periphery) of one or both of the shell 1306 and the mount1308. The adhesive secures the shell 1306 to the mount 1308 and providesstructural integrity, but may also seal the interface between the twocomponents and thereby isolate the interior of the electronics housing1304 from outside contamination.

In the illustrated embodiment, the sensor control device 1302 mayfurther include a plug assembly 1310 that may be coupled to theelectronics housing 1304. The plug assembly 1310 may include a sensormodule 1312 (partially visible) interconnectable with a sharp module1314 (partially visible). The sensor module 1312 may be configured tocarry and otherwise include a sensor 1316 (partially visible), and thesharp module 1314 may be configured to carry and otherwise include asharp 1318 (partially visible) used to help deliver the sensor 1316transcutaneously under a user's skin during application of the sensorcontrol device 1302. The sharp module 1314 may include a sharp hub 1320that carries the sharp 1318.

As illustrated, corresponding portions of the sensor 1316 and the sharp1318 extend from the electronics housing 1304 and, more particularly,from the bottom of the mount 1308. The exposed portion of the sensor1316 (alternately referred to as the “tail”) may be received within ahollow or recessed portion of the sharp 1318. The remaining portions ofthe sensor 1316 are positioned within the interior of the electronicshousing 1304.

FIG. 14A is a side view of the sensor applicator 102 of FIG. 1. Asillustrated, the sensor applicator 102 includes a housing 1402 and anapplicator cap 1404 that may be removably coupled to the housing 1402.In some embodiments, the applicator cap 1404 may be threaded to thehousing 1402 and include a tamper ring 1406. Upon rotating (e.g.,unscrewing) the applicator cap 1404 relative to the housing 1402, thetamper ring 1406 may shear and thereby free the applicator cap 1404 fromthe sensor applicator 102. Once the applicator cap 1404 is removed, auser may then use the sensor applicator 102 to position the sensorcontrol device 1302 (FIGS. 13 and 14B) at a target monitoring locationon the user's body.

In some embodiments, the applicator cap 1404 may be secured to thehousing 1402 via a sealed engagement to protect the internal componentsof the sensor applicator 102. In at least one embodiment, for example,an O-ring or another type of sealing gasket may seal an interfacebetween the housing 1402 and the applicator cap 1404. The O-ring orsealing gasket may be a separate component part or alternatively moldedonto one of the housing 1402 and the applicator cap 1404.

FIG. 14B is a cross-sectional side view of the sensor applicator 102. Asillustrated, the sensor control device 1302 may be received within thesensor applicator 102 and the applicator cap 1404 may be coupled to thesensor applicator 102 to secure the sensor control device 1302 therein.The sensor control device 1302 may include one or more radiationsensitive components 1408 arranged within the electronics housing 1304.The radiation sensitive component 1408 can include an electroniccomponent or module such as, but not limited to, a data processing unit,a resistor, a transistor, a capacitor, an inductor, a diode, a switch,or any combination thereof. The data processing unit may comprise, forexample, an application specific integrated circuit (ASIC) configured toimplement one or more functions or routines associated with operation ofthe sensor control device 1302. In operation, the data processing unitmay perform data processing functions, such as filtering and encoding ofdata signals corresponding to a sampled analyte level of the user. Thedata processing unit may also include or otherwise communicate with anantenna for communicating with the reader device 106 (FIG. 1).

In the illustrated embodiment, a cap fill 1410 may be positioned withinthe applicator cap 1404 and may generally help support the sensorcontrol device 1302 within the sensor applicator 102. In one or moreembodiments, the cap fill 1410 may comprise an integral part orextension of the applicator cap 1404, such as being molded with orovermolded onto the applicator cap 1404. In other embodiments, the capfill 1410 may comprise a separate structure fitted within or otherwiseattached to the applicator cap 1404, without departing from the scope ofthe disclosure.

The sensor control device 1302 and, more particularly, the distal endsof the sensor 1316 and the sharp 1318 extending from the bottom of theelectronics housing 1304, may be sterilized while positioned within thesensor applicator 102. More specifically, the fully assembled sensorcontrol device 1302 may be subjected to radiation sterilization 1412,which may be similar to the radiation sterilization 814 of FIGS. 8-12.The radiation sterilization 1412 may be delivered either throughcontinuous processing irradiation or through pulsed beam irradiation. Inpulsed beam irradiation, the beam of radiation sterilization 1412 isfocused at a target location and the component part or device to besterilized is moved to the target location at which point theirradiation is activated to provide a directed pulse of radiation. Theradiation sterilization 1412 is then turned off, and another componentpart or device to be sterilized is moved to the target location and theprocess is repeated.

According to the present disclosure, an external sterilization assembly1414 may be used to help focus the radiation 1412 in sterilizing thedistal ends of the sensor 1316 and the sharp 1318, while simultaneouslypreventing (impeding) propagating radiation 1412 from damaging theradiation sensitive component 1408. As illustrated, the externalsterilization assembly 1414 (hereafter the “assembly 1414”) may includea radiation shield 1416 positioned at least partially external to thesensor applicator 102. The radiation shield 1416 may provide or definean external collimator 1418 configured to help focus the radiation 1412(e.g., beams, waves, energy, etc.) toward the components to besterilized. More specifically, the external collimator 1418 allowstransmission of the radiation 1412 to impinge upon and sterilize thesensor 1316 and the sharp 1318, but prevent the radiation 1412 fromdamaging the radiation sensitive component 1408 within the electronicshousing 1304.

In the illustrated embodiment, the external collimator 1418 is designedto align with an internal collimator 1420 defined by the cap fill 1410.Similar to the external collimator 1418, the internal collimator 1420may help focus the radiation 1412 toward the components to besterilized. As illustrated, the cap fill 1410 may define a radialshoulder 1422 sized to receive and otherwise mate with an end of theradiation shield 1416, and the external collimator 1418 transitions tothe internal collimator 1420 at the radial shoulder 1422. In someembodiments, the transition between the external and internalcollimators 1418, 1420 may be continuous, flush, or smooth. In otherembodiments, however, the transition may be discontinuous or stepped,without departing from the scope of the disclosure.

The external and internal collimators 1418, 1420 may cooperativelydefine a sterilization zone 1424 that focuses the radiation 1412 andinto which the distal ends of the sensor 1316 and the sharp 1318 may bepositioned. The propagating radiation 1412 may traverse thesterilization zone 1424 to impinge upon and sterilize the sensor 1316and the sharp 1318. However, the cap fill 1410 and the radiation shield1416 may each be made of materials that substantially prevent theradiation 1412 from penetrating the inner wall(s) of the sterilizationzone 1424 and thereby damaging the radiation sensitive component 1408within the housing 1304. In other words, the cap fill 1410 and theradiation shield 1416 may each be made of materials having a densitysufficient to absorb the dose of the beam energy being delivered. Insome embodiments, for example, one or both of the cap fill 1410 and theradiation shield 1416 may be made of a material that has a mass densitygreater than 0.9 grams per cubic centimeter (g/cc). In otherembodiments, however, the mass density of a suitable material may beless than 0.9 g/cc, without departing from the scope of the disclosure.Suitable materials for the cap fill 1410 and the radiation shield 1416include, but are not limited to, a high-density polymer, (e.g.,polyethylene, polypropylene, polystyrene, polytetrafluoroethylene,etc.), a metal (e.g., lead, stainless steel, aluminum, etc.), anycombination thereof, or any material having a mass density greater than0.9 g/cc. In at least one embodiment, the cap fill 1410 may be made ofmachined or 3D printed polypropylene and the radiation shield 1416 maybe made of stainless steel.

In some embodiments, the design of the sterilization zone 1424 may bealtered so that one or both of the cap fill 1410 and the radiationshield 1416 may be made of a material that has a mass density less than0.9 g/cc but may still operate to prevent the radiation sterilization1412 from damaging the radiation sensitive component 1408. In suchembodiments, the size (e.g., length) of the sterilization zone 1424 maybe increased such that the propagating electrons from the radiationsterilization 1412 are required to pass through a larger amount ofmaterial before potentially impinging upon the radiation sensitivecomponent 1408. The larger amount of material may help absorb ordissipate the dose strength of the radiation 1412 such that it becomesharmless to the sensitive electronics. In other embodiments, however,the converse may equally be true. More specifically, the size (e.g.,length) of the sterilization zone 1424 may be decreased as long as thematerial for the cap fill 1410 and/or the radiation shield 1416 exhibitsa large enough mass density.

The sterilization zone 1424 defined by the external and internalcollimators 1418, 1420 can exhibit any suitable cross-sectional shapenecessary to properly focus the radiation 1412 on the sensor 1316 andthe sharp 1318 for sterilization. In the illustrated embodiment, forexample, the external collimator 1418 is conical or frustoconical inshape, but the internal collimator 1420 exhibits a circularcross-sectional shape with parallel sides. In other embodiments,however, one or both of the external and internal collimators 1418, 1420may exhibit a polygonal cross-sectional shape, such as cubic orrectangular (e.g., including parallelogram), without departing from thescope of the disclosure.

In the illustrated embodiment, the sterilization zone 1424 provides afirst aperture 1426 a defined by the external collimator 1418 and asecond aperture 1426 b defined by the internal collimator 1420, wherethe first and second apertures 1426 a,b are located at opposing ends ofthe sterilization zone 1424. The first aperture 1426 a permits theradiation 1412 to enter the sterilization zone 1424, and the secondaperture 1426 b provides a location where radiation 1412 can impact thesensor 1316 and the sharp 1318. In the illustrated embodiment, thesecond aperture 1426 b also provides a location where the sensor 1316and the sharp 1318 may be received into the sterilization zone 1424.

The diameter of the first aperture 1426 a may be larger than thediameter of the second aperture 1426 b. In such embodiments, forexample, the size of the first aperture 1426 a may range between about5.0 mm and about 16.0 mm, and the size of the second aperture 1426 b mayrange between about 0.5 mm and about 3.0 mm. The respective diameters ofthe first and second apertures 1426 a,b, however, may be greater or lessthan the ranges provided herein, without departing from the scope of thedisclosure, and depending on the application. Indeed, the diameters ofthe first and second apertures 1426 a,b need only be large enough toallow a sufficient dose of radiation to impinge upon the sensor 1316 andthe sharp 1318. In some embodiments, the sterilization zone 1424 definedby the external and internal collimators 1418 may be substantiallycylindrical and otherwise exhibit a circular or polygonal cross-section.In such embodiments, the first and second apertures 1426 a,b may exhibitidentical diameters and the walls of the sterilization zone 1424 may besubstantially parallel between the first and second ends of thesterilization zone 1424.

In some embodiments, a cap seal 1428 (shown in dashed lines) may bearranged at the interface between the cap fill 1410 and the radiationshield 1416. The cap seal 1428 may comprise a radiation permeablemicrobial barrier. In some embodiments, for example, the cap seal 1428may be made of a synthetic material (e.g., a flash-spun high-densitypolyethylene fiber), such as TYVEK® available from DuPont®. The cap seal1428 may seal off a portion of the sterilization zone 1424 to help formpart of a sealed region 1430 configured to isolate the sensor 1316 andthe sharp 1318 from external contamination.

The sealed region 1430 may include (encompass) select portions of theinterior of the electronics housing 1304 and the sterilization zone1424. In one or more embodiments, the sealed region 1430 may be definedand otherwise formed by at least the cap seal 1428, a first or “top”seal 1432 a, and a second or “bottom” seal 1432 b. The cap seal 1428 andthe top and bottom seals 1432 a,b may each create corresponding barriersat their respective sealing locations, thereby allowing thesterilization zone 1424 containing the sensor 1316 and the sharp 1318 tobe terminally sterilized.

The top seal 1432 a may be arranged to seal the interface between thesharp hub 1320 and the top of the electronics housing 1304 (i.e., theshell 1306 of FIG. 13) and thereby prevent contaminants from migratinginto the interior of the electronics housing 1304. In some embodiments,the top seal 1432 a may form part of the sharp hub 1320, such as beingovermolded onto the sharp hub 1320. In other embodiments, however, thetop seal 1432 a may form part of or be overmolded onto the top surfaceof the shell 1306. In yet other embodiments, the top seal 1432 a maycomprise a separate structure, such as an O-ring or the like, thatinterposes the sharp hub 1320 and the top surface of the shell 1306,without departing from the scope of the disclosure.

The bottom seal 1432 b may be arranged to seal the interface between thecap fill 1410 and the bottom of electronics housing 1304 (i.e., themount 1308 of FIG. 13). The bottom seal 1432 b may prevent contaminantsfrom migrating into the sterilization zone 1424 and from migrating intothe interior of the electronics housing 1304. In some embodiments, thebottom seal 1432 b may form part of the cap fill 1410, such as beingovermolded onto the top of the cap fill 1410. In other embodiments, thebottom seal 1432 b may form part of or be overmolded onto the bottom ofthe mount 1308. In yet other embodiments, the bottom seal 1432 b maycomprise a separate structure, such as an O-ring or the like, thatinterposes the cap fill 1410 and the bottom of the mount 1308, withoutdeparting from the scope of the disclosure.

Upon loading the sensor control device 1302 into the sensor applicator102 and securing the applicator cap 1404 to the sensor applicator 102,the top and bottom seals 1432 a,b may compress and generatecorresponding sealed interfaces. The top and bottom seals 1432 a,b maybe made of a variety of materials capable of generating a sealedinterface between opposing structures. Suitable materials include, butare not limited to, silicone, a thermoplastic elastomer (TPE),polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

It is noted that, while the sensor 1316 and the sharp 1318 extend fromthe bottom of the electronics housing 1304 and into the sterilizationzone 1424 generally concentric with a centerline of the sensorapplicator 102 and the applicator cap 1404, it is contemplated herein tohave an eccentric arrangement. More specifically, in at least oneembodiment, the sensor 1316 and the sharp 1318 may extend from thebottom of the electronics housing 1304 eccentric to the centerline ofthe sensor applicator 102 and the applicator cap 1404. In suchembodiments, the external and internal collimators 1418, 1420 may bere-designed and otherwise configured such that the sterilization zone1424 is also eccentrically positioned to receive the sensor 1316 and thesharp 1318, without departing from the scope of the disclosure.

In some embodiments, the external sterilization assembly 1414 mayfurther include a sterilization housing or “pod” 1434 coupled to orforming part of the radiation shield 1416. The sterilization pod 1434provides and otherwise defines a chamber 1436 sized to receive all or aportion of the sensor applicator 102. Once properly seated (received)within the sterilization pod 1434, the sensor applicator 102 may besubjected to the radiation sterilization 1412 to sterilize the sensor1316 and the sharp 1318. The sterilization pod 1434 may be made of anyof the materials mentioned herein for the radiation shield 1416 to helpprevent the radiation 1412 from propagating through the walls of thesterilization pod 1434.

In some embodiments, the radiation shield 1416 may be removably coupledto the sterilization pod 1434 using one or more mechanical fasteners1438 (one shown), but could alternatively be removably coupled via aninterference fit, a snap fit engagement, etc. Removably coupling theradiation shield 1416 to the sterilization pod 1434 enables theradiation shield 1416 to be interchangeable with differently designed(sized) shields to fit particular sterilization applications for varyingtypes and designs of the sensor applicator 102. Accordingly, thesterilization pod 1434 may comprise a universal mount that allows theradiation shield 1416 to be interchanged with other shield designshaving different parameters for the external collimator 1418, as needed.

In some embodiments, the external sterilization assembly 1414 mayfurther include a mounting tray 1440 coupled to or forming part of thesterilization pod 1434. The sterilization pod 1434 may be removablycoupled to the mounting tray 1440 using, for example, one or moremechanical fasteners 1442 (one shown). The mounting tray 1440 mayprovide or define a central aperture 1444 sized to receive the sensorapplicator 102 and alignable with the chamber 1436 to enable the sensorapplicator 102 to enter the chamber 1436. As described below, in someembodiments, the mounting tray 1440 may define a plurality of centralapertures 1444 for receiving a corresponding plurality of sensorapplicators for sterilization.

FIG. 15 is a cross-sectional side view of the sensor applicator 102 andanother example embodiment of the external sterilization assembly 1414,according to one or more additional embodiments. As illustrated, thesensor control device 1302 is again received within the sensorapplicator 102 and the applicator cap 1404 is coupled to the housing1402 to secure the sensor control device 1302 therein.

In the illustrated embodiment, the applicator cap 1404 may be invertedand may define or otherwise provide a cap post 1502 sized to receive thedistal ends of the sensor 1316 and the sharp 1318 extending from thebottom of the electronics housing 1304. The cap post 1502 helps providea portion of the sealed region 1430 configured to isolate the sensor1316 and the sharp 1318 from external contamination. In the illustratedembodiment, the sealed region 1430 may be defined and otherwise formedby the cap post 1502 and the top and bottom seals 1432 a,b, which createcorresponding barriers at their respective sealing locations. The topseal 1432 a may again be arranged to seal the interface between thesharp hub 1320 and the top of the electronics housing 1304 (i.e., theshell 1306 of FIG. 13), and the bottom seal 1432 b may be arranged toseal an interface between the applicator cap 1404 and the bottom ofelectronics housing 1304 (i.e., the mount 1308 of FIG. 13). In someembodiments, the bottom seal 1432 b may interpose the cap post 1502 andthe bottom of electronics housing 1304.

In the illustrated embodiment, the radiation shield 1416 may bepositioned external to the sensor applicator 102 and may extend into theinverted portion of the applicator cap 1404. The external collimator1418 provided by the radiation shield 1416 defines a sterilization zone1504 configured to focus the radiation 1412 toward the sensor 1316 andthe sharp 1318. In the illustrated embodiment, the cap post 1502 andportions of the sensor 1316 and the sharp 1318 positioned within the cappost 1502 extend into the sterilization zone 1504. Propagating radiation1412 may traverse the sterilization zone 1504 to sterilize the sensor1316 and the sharp 1318 positioned within the cap post 1502. Asindicated above, however, the radiation shield 1416 may be made of amaterial that substantially prevents the radiation 1412 from penetratingthe wall(s) of the sterilization zone 1504 and thereby damaging theradiation sensitive component 1408 within the housing 1304.

In the illustrated embodiment, the external collimator 1418 defines afirst aperture 1506 a at a first end of the sterilization zone 1504 anda second aperture 1506 b at the second end of the sterilization zone1504. The first aperture 1506 a permits the radiation 1412 to enter thesterilization zone 1504, and the second aperture 1506 b provides alocation where radiation 1412 is focused toward the sensor 1316 and thesharp 1318. The second aperture 1506 b may also provide a location wherethe sensor 1316 and the sharp 1318 positioned within the cap post 1502may be received into the sterilization zone 1504.

As illustrated, the external collimator 1418 and associatedsterilization zone 1504 are conical or frustoconical in shape, and thediameter of the first aperture 1506 a is larger than the diameter of thesecond aperture 1506 b. The size of the first aperture 1506 a may rangebetween about 5.0 mm and about 16.0 mm, and the size of the secondaperture 1506 b may range between about 0.5 mm and about 3.0 mm, butcould alternatively be greater or less than the provided ranges, withoutdeparting from the scope of the disclosure. Indeed, the sizes of theapertures 1506 a,b may vary depending on the scale of the device. Inother embodiments, however, the external collimator 1418 and associatedsterilization zone 1504 may be substantially cylindrical and otherwiseexhibit a circular or polygonal cross-section where the first and secondapertures 1506 a,b exhibit substantially identical diameters and thewalls of the sterilization zone 1504 are substantially parallel.

FIG. 16 is a cross-sectional side view of the sensor applicator 102 andanother example embodiment of the external sterilization assembly 1414,according to one or more additional embodiments. As illustrated, thesensor control device 1302 is again received within the sensorapplicator 102 and the applicator cap 1404 is coupled to the housing1402 to secure the sensor control device 1302 therein.

In the illustrated embodiment, the applicator cap 1404 may again beinverted and may define or otherwise provide a cap post 1602 sized toreceive the distal ends of the sensor 1316 and the sharp 1318 extendingfrom the bottom of the electronics housing 1304. Moreover, the radiationshield 1416 may be positioned external to the sensor applicator 102 andmay extend into the inverted portion of the applicator cap 1404. Morespecifically, the radiation shield 1416 may extend into the invertedportion of the applicator cap 1404 and to the bottom of the cap post1602. Unlike the cap post 1502 of FIG. 15, however, the bottom of thecap post 1602 may be open ended. In some embodiments, a cap seal 1604may be arranged at the interface between the cap post 1602 and theradiation shield 1416 to seal off the open end of the cap post 1602. Thecap seal 1604 may be similar to the cap seal 1428 of FIG. 14B, andtherefore will not be described again.

In some embodiments, a cap fill 1606 may be positioned within theapplicator cap 1404. In one or more embodiments, the cap fill 1606 maycomprise an integral part or extension of the applicator cap 1404, suchas being molded with or overmolded onto the applicator cap 1404. Inother embodiments, the cap fill 1606 may comprise a separate structurefitted within or otherwise attached to the applicator cap 1404, withoutdeparting from the scope of the disclosure. The cap fill 1606 may alsoprovide or otherwise define an internal collimator 1608 that may helpfocus the radiation 1412 toward the components to be sterilized. In atleast one embodiment, as illustrated, the cap post 1602 may be receivedwithin the internal collimator 1608.

The external and internal collimators 1418, 1608 may cooperativelydefine a sterilization zone 1610 that focuses the radiation 1412 towardthe sensor 1316 and the sharp 1318. The propagating radiation 1412 maytraverse the sterilization zone 1610 to impinge upon and sterilize thesensor 1316 and the sharp 1318. However, the cap fill 1606 and theradiation shield 1416 may each be made of any of the materials mentionedherein that substantially prevent the radiation 1412 from penetratingthe inner wall(s) of the sterilization zone 1610 and thereby damagingthe radiation sensitive component 1408 within the housing 1304. In atleast one embodiment, the cap fill 1606 may be made of machined or 3Dprinted polypropylene and the radiation shield 1416 may be made ofstainless steel.

The external and internal collimators 1418, 1608 can exhibit anysuitable cross-sectional shape necessary to properly focus the radiation1412 toward the sensor 1316 and the sharp 1318 for sterilization. In theillustrated embodiment, for example, the external collimator 1418 isconical or frustoconical in shape, and the internal collimator 1608 issubstantially cylindrical with internal walls that are substantiallyparallel. In other embodiments, however, the external and internalcollimators 1418, 1608 may exhibit other cross-sectional shapes, withoutdeparting from the scope of the disclosure.

In the illustrated embodiment, the external collimator 1418 defines afirst aperture 1612 a that permits the radiation 1412 to enter thesterilization zone 1610 and a second aperture 1612 b positioned at ornear the bottom opening to the cap post 1602 to focus the radiation 1412at the sensor 1316 and the sharp 1318 positioned within the cap post1602. The diameter of the first aperture 1612 a is larger than thediameter of the second aperture 1612 b and, as with prior embodiments,the size of the first aperture 1612 a may range between about 5.0 mm andabout 16.0 mm, and the size of the second aperture 1612 b may rangebetween about 0.5 mm and about 3.0 mm. In the illustrated embodiment,the external collimator 1418 funnels the electrons of the radiation 1412toward the bottom opening to the cap post 1602 and amplifies theelectrons at the sensor 1316 and the sharp 1318.

The cap seal 1604 may be arranged at the interface between the radiationshield 1416 and the cap post 1602 and/or the cap fill 1606. The cap seal1604 may seal off a portion of the sterilization zone 1610 to help formpart of the sealed region 1430 configured to isolate the sensor 1316 andthe sharp 1318 from external contamination. The sealed region 1430 mayinclude (encompass) select portions of the interior of the electronicshousing 1304 and the sterilization zone 1610. In the illustratedembodiment, the sealed region 1430 may be defined and otherwise formedby the cap post 1602 and the top and bottom seals 1432 a,b, which createcorresponding barriers at their respective sealing locations. The bottomseal 1432 b may be arranged to seal an interface between the applicatorcap 1404 and the bottom of electronics housing 1304 (i.e., the mount1308 of FIG. 13).

FIGS. 17A and 17B are partially exploded isometric top and bottom views,respectively, of one example of the external sterilization assembly1414, according to one or more embodiments. In at least one embodiment,the assembly 1414 may be designed and otherwise configured toaccommodate and help sterilize a plurality of sensor applicators 102(i.e., with the sensor control devices positioned therein). In theillustrated embodiment, the mounting tray 1440 defines a plurality ofcentral apertures 1444 (FIG. 17A), and a plurality of sterilization pods1434 may be aligned with the central apertures 1444 and coupled to themounting tray 1440. The sensor applicators 102 may be received withinthe sterilization pods 1434 via the central apertures 1444, and eachsterilization pod 1434 may have a corresponding shield 1416 (FIG. 17B)coupled thereto or otherwise forming part thereof.

In some embodiments, the assembly 1414 may further include a cover 1702matable with the mounting tray 1440. The cover 1702 may include ordefine a plurality of apertures 1106 (FIG. 17B) sized to receive thetops of the sensor applicators 102 when the cover 1702 is placed on topof the mounting tray 1440. In some embodiments, the cover 1702 may bemade of any of the materials mentioned herein for the radiation shield1416 to help prevent the radiation sterilization from propagatingthrough the walls of the assembly 1414. With the cover 1702 mated withthe mounting tray 1414, the sensor applicators 102 may be encapsulatedor otherwise encased within the assembly 1414.

Embodiments disclosed herein include:

D. An external sterilization assembly that includes a radiation shieldpositionable external to a medical device having a part requiringsterilization and a radiation sensitive component, and a collimatordefined by the radiation shield and alignable with the part requiringsterilization, wherein the collimator focuses radiation from a radiationsterilization process toward the part requiring sterilization and theradiation shield prevents the radiation from damaging the radiationsensitive component.

E. An external sterilization assembly that includes a radiation shieldpositionable external to a sensor applicator that includes a housing, acap coupled to the housing, and a sensor control device positionedwithin the housing, wherein the sensor control device includes anelectronics housing, a radiation sensitive component arranged within theelectronics housing, and a sensor and a sharp extending from theelectronics housing. The external sterilization assembly furtherincluding an external collimator defined by the radiation shield andalignable with the sensor and the sharp, wherein the external collimatorfocuses radiation from a radiation sterilization process toward thesensor and the sharp and the radiation shield prevents the radiationfrom damaging the radiation sensitive component.

F. A method including arranging a radiation shield external to a sensorapplicator having a housing, a cap coupled to the housing, and a sensorcontrol device positioned within the housing, wherein the sensor controldevice includes an electronics housing, a radiation sensitive componentarranged within the electronics housing, and a sensor and a sharpextending from the electronics housing. The method further includingfocusing radiation from a radiation sterilization process toward thesensor and the sharp with an external collimator defined by theradiation shield, and preventing the radiation from damaging theradiation sensitive component with the radiation shield.

Each of embodiments D, E, and F may have one or more of the followingadditional elements in any combination: Element 1: wherein the radiationshield is made of a material selected from the group consisting of ahigh-density polymer, a metal, and any combination thereof. Element 2:wherein the radiation sensitive component is selected from the groupconsisting of an electronic module, a chemical solution, and anycombination thereof. Element 3: wherein the collimator comprises across-sectional shape selected from the group consisting of conical,frustoconical, pyramidal, circular, cubic, rectangular, and anycombination thereof. Element 4: further comprising a cap thatencapsulates the part requiring sterilization and provides a sealedbarrier. Element 5: wherein the radiation shield defines an internalcavity that receives the medical device, and the collimator focuses theradiation into the internal cavity.

Element 6: wherein the radiation shield is made of a material selectedfrom the group consisting of a high-density polymer, a metal, and anycombination thereof. Element 7: wherein the external collimatorcomprises a cross-sectional shape selected from the group consisting ofconical, frustoconical, pyramidal, circular, cubic, rectangular, and anycombination thereof. Element 8: further comprising a sterilization poddefining a chamber that receives at least a portion of the sensorapplicator, wherein the radiation shield is removably coupled to thesterilization pod. Element 9: further comprising a mounting tray thatdefines a central aperture alignable with the chamber and sized toreceive the sensor applicator, and a cover matable with the mountingtray to encase the sensor applicator. Element 10: wherein the externalcollimator is alignable with an internal collimator defined by a capfill positioned within the cap, and wherein the external and internalcollimators cooperatively define a sterilization zone into which thesensor and the sharp are received. Element 11: wherein the externalcollimator comprises a cross-sectional shape selected from the groupconsisting of conical, frustoconical, pyramidal, circular, cubic,rectangular, and any combination thereof. Element 12: further comprisinga cap seal arranged at an interface between the external and internalcollimators. Element 13: wherein the cap is inverted and provides a cappost that receives the sensor and the sharp. Element 14: wherein theexternal collimator and the cap post cooperatively define asterilization zone and the sensor and the sharp positioned within thecap post extend into the sterilization zone.

Element 15: wherein arranging the radiation shield external to thesensor applicator comprises positioning the sensor applicator within achamber defined by a sterilization pod, the radiation shield beingremovably coupled to the sterilization pod. Element 16: whereinpositioning the sensor applicator within the chamber defined by thesterilization pod further comprise extending the sensor applicatorthrough a central aperture defined by a mounting tray and aligned withthe chamber, positioning a cover on the mounting tray and therebyencasing the sensor applicator, and undertaking the radiationsterilization process while the sensor applicator is encased by thecover. Element 17: wherein the external collimator comprises across-sectional shape selected from the group consisting of conical,frustoconical, pyramidal, circular, cubic, rectangular, and anycombination thereof.

By way of non-limiting example, exemplary combinations applicable to D,E, and F include: Element 8 with Element 9; Element 10 with Element 11;Element 10 with Element 12; Element 13 with Element 14; and Element 15with Element 16.

Hybrid Sterilization Assemblies

Referring again briefly, to FIG. 1, prior to being delivered to an enduser, the sensor control device 104 must be sterilized to render theproduct free from viable microorganisms. The sensor 110 is commonlysterilized using radiation sterilization, such as electron beam(“e-beam”) irradiation. Radiation sterilization, however, can damage theelectronic components within the sensor control device 104, which arecommonly sterilized via gaseous chemical sterilization (e.g., usingethylene oxide). Gaseous chemical sterilization, however, can damage theenzymes or other chemistry and biologics included on the sensor 110.

In the past, this sterilization incompatibility has been circumvented byseparating the sensor 110 and the electronic components and sterilizingeach individually. This approach, however, requires additional parts,packaging, process steps, and final assembly by the user, whichintroduces a possibility of user error. According to the presentdisclosure, the sensor control device 104, or any device requiringterminal sterilization, may be properly sterilized using externalsterilization assemblies designed to focus sterilizing radiation (e.g.,beams, waves, energy, etc.) toward component parts requiringsterilization, while simultaneously preventing the propagating radiationfrom disrupting or damaging sensitive electronic components.

FIG. 18 is an isometric view of an example sensor control device 1802,according to one or more embodiments of the present disclosure. Thesensor control device 1802 may be the same as or similar to the sensorcontrol device 104 of FIG. 1 and, therefore, may be used in conjunctionwith the sensor applicator 102 (FIG. 1), which delivers the sensorcontrol device 1802 to a target monitoring location on a user's skin.Accordingly, the sensor control device 1802 also requires propersterilization prior to being used.

As illustrated, the sensor control device 1802 includes an electronicshousing 1804 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing1804 may exhibit other cross-sectional shapes, such as ovoid (e.g.,pill- or egg-shaped), a squircle, polygonal, or any combination thereof,without departing from the scope of the disclosure. The electronicshousing 1804 may be configured to house or otherwise contain variouselectronic components used to operate the sensor control device 1802.

The electronics housing 1804 may include a shell 1806 and a mount 1808that is matable with the shell 1806. The shell 1806 may be secured tothe mount 1808 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic or laser welding, one or more mechanicalfasteners (e.g., screws), or any combination thereof. In some cases, theshell 1806 may be secured to the mount 1808 such that a sealed interfaceis generated therebetween. In such embodiments, a gasket or other typeof seal material may be positioned at or near the outer diameter(periphery) of the shell 1806 and the mount 1808, and securing the twocomponents together may compress the gasket and thereby generate asealed interface. In other embodiments, an adhesive may be applied tothe outer diameter (periphery) of one or both of the shell 1806 and themount 1808. The adhesive secures the shell 1806 to the mount 1808 andprovides structural integrity, but may also seal the interface betweenthe two components and thereby isolate the interior of the electronicshousing 1804 from outside contamination.

In the illustrated embodiment, the sensor control device 1802 mayoptionally include a plug assembly 1810 that may be coupled to theelectronics housing 1804. The plug assembly 1810 may include a sensormodule 1812 (partially visible) interconnectable with a sharp module1814 (partially visible). The sensor module 1812 may be configured tocarry and otherwise include a sensor 1816 (partially visible), and thesharp module 1814 may be configured to carry and otherwise include anintroducer or sharp 1818 (partially visible) used to help deliver thesensor 1816 transcutaneously under a user's skin during application ofthe sensor control device 1802. In the illustrated embodiment, the sharpmodule 1814 includes a sharp hub 1820 that carries the sharp 1818.

As illustrated, corresponding portions of the sensor 1816 and the sharp1818 extend distally from the electronics housing 1804 and, moreparticularly, from the bottom of the mount 1808. In at least oneembodiment, the exposed portion of the sensor 1816 (alternately referredto as the “tail”) may be received within a hollow or recessed portion ofthe sharp 1818. The remaining portions of the sensor 1816 are positionedwithin the interior of the electronics housing 1804.

FIG. 19A is a side view of the sensor applicator 102 of FIG. 1. Asillustrated, the sensor applicator 102 includes a housing 1902 and anapplicator cap 1904 that may be removably coupled to the housing 1902.In some embodiments, the applicator cap 1904 may be threaded to thehousing 1902 and include a tamper ring 1906. Upon rotating (e.g.,unscrewing) the applicator cap 1904 relative to the housing 1902, thetamper ring 1906 may shear and thereby free the applicator cap 1904 fromthe sensor applicator 102. Once the applicator cap 1904 is removed, auser may then use the sensor applicator 102 to position the sensorcontrol device 1802 (FIG. 18) at a target monitoring location on theuser's body.

FIG. 19B is a partial cross-sectional side view of the sensor applicator102. As illustrated, the sensor control device 1802 may be receivedwithin the sensor applicator 102 and the applicator cap 1904 may becoupled to the housing 1902 to secure the sensor control device 1802within. The sensor control device 1802 may include one or more radiationsensitive components 1908 arranged within the electronics housing 1804.The radiation sensitive component 1908 can include an electroniccomponent or module such as, but not limited to, a data processing unit,a resistor, a transistor, a capacitor, an inductor, a diode, a switch,or any combination thereof. The data processing unit may comprise, forexample, an application specific integrated circuit (ASIC) configured toimplement one or more functions or routines associated with operation ofthe sensor control device 1802. In operation, the data processing unitmay perform data processing functions, such as filtering and encoding ofdata signals corresponding to a sampled analyte level of the user. Thedata processing unit may also include or otherwise communicate with anantenna for communicating with the reader device 106 (FIG. 1).

In the illustrated embodiment, an applicator insert 1910 may bepositioned within the applicator cap 1904 and may generally help supportthe sensor control device 1802 within the sensor applicator 102. In oneembodiment, the applicator insert 1910 may comprise an integral part orextension of the applicator cap 1904, such as being molded with orovermolded onto the applicator cap 1904. In other embodiments, theapplicator insert 1910 may comprise a separate structure fitted withinor otherwise attached to the applicator cap 1904, without departing fromthe scope of the disclosure. In such embodiments, for example, screwingthe applicator cap 1904 onto the housing 1908 may progressively advancean inner surface 1912 of the applicator insert 1910 into axial and/orradial engagement with a bottom edge, surface or portion of theapplicator insert 1910 to thereby axially secure the applicator insert1910 within the applicator cap 1904.

The sensor applicator 102 may further include a sheath 1914 and, in someembodiments, the applicator insert 1910 may engage the sheath 1914 torotationally fix the applicator insert 1910 within the applicator cap1904. More specifically, the applicator insert 1910 may provide orotherwise define one or more radial alignment features 1916 (one shown)matable with a corresponding groove or slot 1918 defined in the sheath1914. The radial alignment feature 1916 may comprise, for example, arail, a flag, a tab, a protrusion, or the like extending from the mainbody of the applicator insert 1910 and may mate with the slot 1918 bysliding the radial alignment feature 1916 longitudinally into the slot1918, for example. Mating engagement between the radial alignmentfeature 1916 and the slot 1918 may also help angularly (rotationally)orient the applicator insert 1910 relative to the sensor control device1802. As will be appreciated, however, the matable structures mayalternatively be reversed, where the radial alignment feature 1916 isinstead provided on the sheath 1914 and the slot 1918 is provided on theapplicator insert 1910.

The applicator insert 1910 may provide and otherwise define an internalcollimator 1920 a, which forms part of a hybrid sterilization assemblydescribed in more detail below. The internal collimator 1920 a may helpdefine a portion of a sterilization zone 1922 and, more particularly, anupper portion 1924 of the sterilization zone 1922. When the sensorcontrol device 1802 is installed in the sensor applicator 102, thedistal ends of the sensor 1816 and the sharp 1818 may extend from thebottom of the electronics housing 1804 and reside within the upperportion 1924.

In some embodiments, a microbial barrier 1926 a may be positioned at anopening to the upper portion 1924 of the sterilization zone 1922. Themicrobial barrier 1926 a may help seal at least some of the upperportion 1924 of the sterilization zone 1922 to thereby isolate thedistal ends of the sensor 1816 and the sharp 1818 from externalcontamination. The microbial barrier 1926 a may be made of a radiationpermeable material, such as a synthetic material (e.g., a flash-spunhigh-density polyethylene fiber). One example synthetic materialcomprises TYVEK®, available from DuPont®. In other embodiments, however,the microbial barrier 1926 a may comprise, but is not limited to, tape,paper, film, foil, or any combination thereof. In at least oneembodiment, the microbial barrier 1926 a may comprise or otherwise beformed by a thinned portion of the applicator insert 1910, withoutdeparting from the scope of the disclosure.

In some embodiments, a moisture barrier 1926 b may be positioned orotherwise arranged at an opening 1928 to the applicator cap 1904.Similar to the microbial barrier 1926 a, the moisture barrier 1926 b maybe configured to help isolate portions of the sensor applicator 102 fromexternal contamination. The moisture barrier 1926 b may be made of anyof the materials mentioned above with reference to the microbial barrier1926 a. In at least one embodiment, however, the moisture barrier 1926 bmay comprise a thinned portion of the applicator cap 1904, withoutdeparting from the scope of the disclosure. In such embodiments, theopening 1928 would not be necessary.

FIGS. 20A-20C are various views of the applicator insert 1910, accordingto one or more embodiments of the disclosure. More specifically, FIG.20A is an isometric top view, FIG. 20B is an isometric bottom view, andFIG. 20C is an isometric cross-sectional view of the applicator insert1910. As illustrated, the applicator insert 1910 includes a generallycylindrical body 2002 having a first or top end 2004 a and a second orbottom end 2004 b opposite the top end 2004 a. The top end 2004 a isgenerally closed except for an aperture 2005 sized to receive the sensor1816 (FIG. 19B) and the sharp 1918 (FIG. 19B) therethrough, and thebottom end 2004 b is generally open.

The radial alignment feature 1916 described above is provided on asidewall of the body 2002. In some embodiments, additional radialalignment features 2006 (three shown) may be provided or otherwisedefined on the sidewall of the body 2002. In the illustrated embodiment,the additional radial alignment features 2006 each comprise a pair oflongitudinally-extending tabs or projections 2008 angularly offset fromeach other on the sidewall to cooperatively define a slot 2010therebetween. The slot 2010 may be size to receive a projection or tabprovided on the sheath 1914 (FIG. 19B) to help angularly (rotationally)orient the applicator insert 1910 relative to the sensor control device1802 (FIG. 19B). Moreover, similar to the arrangement of the radialalignment feature 1916, the matable structures of the additional radialalignment features 2006 may alternatively be reversed, where theadditional radial alignment features 2006 are instead provided on thesheath 1914 and the corresponding projection or tab is provided on theapplicator insert 1910.

As best seen in FIGS. 20A and 20C, the applicator insert 1910 mayfurther include one or more sensor locating features 2012 that may beused to also help properly orient the applicator insert 1910 relative tothe sensor control device 1802 (FIG. 19B) within the sensor applicator102 (FIG. 19B). As illustrated, the sensor locating features 2012 may bedefined on and extend axially from the top end 2004 a of the body 2002.The sensor locating features 2012 may be sized to be received withincorresponding apertures defined in the bottom of the sensor controldevice 1802. In the illustrated embodiment, the sensor locating features2012 comprise cylindrical projections, but could alternatively compriseother types of structural features suitable for mating with thecorresponding features on the bottom of the sensor control device 1802.The sensor locating features 2012, in conjunction with the radialalignment feature 1916 and the additional radial alignment features2006, may prove especially advantageous in embodiments where the sensorcontrol device 1802 comprises an eccentric orientation, where the sensor1916 and the sharp 1918 are not concentric with the centerline of thesensor control device.

The internal collimator 1920 a may be formed or otherwise provided atthe top end 2004 a of the applicator insert 1910. As best seen in FIG.20C, the internal collimator 1920 a may be defined by the applicatorinsert 1910 and may include a collimating insert 2014 and a gasket 2016.The internal collimator 1920 a may be fabricated by first fabricating orotherwise producing the collimating insert 2014. The applicator insert1910 may then be overmolded onto the collimating insert 2014. Also, thecollimating insert 2014 could be insert molded into the applicatorinsert 1910. Accordingly, the applicator insert 1910 may be made of ahard plastic. The gasket 2016 may then be molded onto the applicatorinsert 1910 in a second shot molding (overmolding) process.

The collimating insert 2014 may be made of a material that reduces orprevents sterilizing radiation from penetrating therethrough. Suitablematerials for the collimating insert 2014 include, but are not limitedto, a high-density polymer, (e.g., polyethylene, polypropylene,polystyrene, polytetrafluoroethylene, polyamide, etc.), a metal (e.g.,lead, tungsten, stainless steel, aluminum, etc.), a composite material,or any combination thereof. In some embodiments, the collimating insert2014 may be made of any material that has a mass density greater than0.9 grams per cubic centimeter (g/cc).

The gasket 2016 may be made of any material that helps form a sealedinterface with the bottom of the electronics housing 1804 (FIG. 19B)when the applicator insert 1910 is installed in the sensor applicator102 (FIG. 19B). Suitable materials for the gasket 2016 include, but arenot limited to, silicone, a thermoplastic elastomer (TPE),polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof. Asillustrated, the gasket 2016 may fill a void 2018 defined by theapplicator insert 1910 and may provide an annular projection 2020 thatprotrudes past and/or from the upper surface of the top end 2004 a ofthe body 2002. The annular projection 2020 may prove advantageous in notonly facilitating a sealed interface, but also in helping to take uptolerances as the applicator insert 1910 is installed in the sensorapplicator 102. Moreover, the mass of the gasket 2016 may also helpabsorb radiation during the sterilization processes described below,thus providing another layer of protection against radiationpropagation. In at least one embodiment, the gasket 2016 may be largeenough or of a material that absorbs sufficient radiation that thecollimating insert 2014 may be omitted from the internal collimator 1920a.

FIG. 21 is another cross-sectional side view of the sensor applicator102 of FIG. 19A showing a hybrid sterilization assembly 2102, accordingto one or more embodiments of the disclosure. The hybrid sterilizationassembly 2102, alternately referred to as a “split collimation assembly”or “cooperative collimation assembly,” may be used to help sterilize thesensor control device 1802 and, more particularly, the distal ends ofthe sensor 1816 and the sharp 1818 extending from the bottom of theelectronics housing 1804 while positioned within the sensor applicator102. More specifically, the fully assembled sensor control device 1802may be subjected to radiation sterilization 2104 to sterilize theexposed portions of the sensor 1816 and the sharp 1818. Suitableradiation sterilization 2104 processes include, but are not limited to,electron beam (e-beam) irradiation, gamma ray irradiation, X-rayirradiation, or any combination thereof.

The radiation sterilization 2104 may be delivered either throughcontinuous processing irradiation or through pulsed beam irradiation. Inpulsed beam irradiation, the beam of radiation sterilization 2104 isfocused at a target location and the component part or device to besterilized is moved to the target location at which point theirradiation is activated to provide a directed pulse of radiation. Theradiation sterilization 2104 is then turned off, and another componentpart or device to be sterilized is moved to the target location and theprocess is repeated.

According to the present disclosure, the hybrid sterilization assembly2102 may be used to help focus the radiation 2104 in sterilizing thedistal ends of the sensor 1816 and the sharp 1818, while simultaneouslypreventing (impeding) propagating radiation 2104 from damaging theradiation sensitive component 1908. As illustrated, the hybridsterilization assembly 2102 (hereafter the “assembly 2102”) may includethe internal collimator 1920 a previously described above and anexternal collimator 1920 b. As illustrated, the internal collimator 1920a may be arranged within the sensor applicator 102, and the externalcollimator 1920 b may extend into the sensor applicator 102 (i.e., theapplicator cap 1904) by penetrating the opening 1928 to the applicatorcap 1904. The internal and external collimators 1920 a,b maycooperatively define the sterilization zone 1922 that focuses theradiation 2104 (e.g., beams, waves, energy, etc.) to impinge upon andsterilize the sensor 1816 and the sharp 1818.

In the illustrated embodiment, the external collimator 1920 b isdesigned to align with the internal collimator 1920 a and, moreparticularly, with the collimating insert 2014. In at least oneembodiment, for example, the collimating insert 2014, may define aradial shoulder 2106 sized to receive and otherwise mate with an end ofthe external collimator 1920 b extended into the applicator cap 1904.The external collimator 1920 b may transition to the internal collimator1920 a at the radial shoulder 2106. In some embodiments, the transitionbetween the internal and external collimators 1920 a,b may becontinuous, flush, or smooth. In other embodiments, however, thetransition may be discontinuous or stepped, without departing from thescope of the disclosure.

Similar to the collimating insert 2014 of the internal collimator 1920a, the external collimator 1920 b may be made of a material thatsubstantially prevents the radiation 2104 from penetrating the innerwall(s) of the sterilization zone 1922 and thereby damaging theradiation sensitive component 1908 within the electronics housing 1804.Accordingly, the external collimator 1920 b may be made of any of thematerials mentioned herein as being suitable for the collimating insert2014. In at least one embodiment, the collimating insert 2014 and theexternal collimator 1920 b may each be made of stainless steel.Moreover, however, as mentioned above the gasket 2016 may also provide adegree of shielding or protection against the radiation from damagingthe radiation sensitive component 1908.

The sterilization zone 1922 defined by the internal and externalcollimators 1920 a,b can exhibit any suitable cross-sectional shapenecessary to properly focus the radiation 2104 on the sensor 1816 andthe sharp 1818 for sterilization. In the illustrated embodiment, forexample, the external collimator 1920 b is conical or frustoconical inshape, and the internal collimator 1920 a exhibits a circularcross-sectional shape with parallel sides. In other embodiments,however, one or both of the internal and external collimators 1920 a,bmay exhibit a polygonal cross-sectional shape, such as cubic orrectangular (e.g., including parallelogram), without departing from thescope of the disclosure.

In the illustrated embodiment, the sterilization zone 1922 provides afirst aperture 2108 a defined by the external collimator 1920 b and asecond aperture 2108 b defined by the internal collimator 1920 a, wherethe first and second apertures 2108 a,b are located at opposing ends ofthe sterilization zone 1922. The first aperture 2108 a permits theradiation 2104 to enter the sterilization zone 1922, and the secondaperture 2108 b provides a location where the sensor 1816 and the sharp1818 may be received into the sterilization zone 1922.

The diameter of the first aperture 2108 a may be larger than thediameter of the second aperture 2108 b. For example, the size of thefirst aperture 2108 a may range between about 5.0 mm and about 16.0 mm,and the size of the second aperture 2108 b may range between about 0.5mm and about 5.0 mm. The respective diameters of the first and secondapertures 2108 a,b, however, may be greater or less than the rangesprovided herein, without departing from the scope of the disclosure, anddepending on the application. Indeed, the diameters of the first andsecond apertures 2108 a,b need only be large enough to allow asufficient dose of radiation to impinge upon the sensor 1816 and thesharp 1818. In embodiments where the sterilization zone 1922 issubstantially cylindrical and otherwise exhibit a circular or polygonalcross-section, the first and second apertures 2108 a,b may exhibitidentical diameters. In such embodiments, the walls of the sterilizationzone 1922 may or may not be substantially parallel between the first andsecond ends of the sterilization zone 1922.

The microbial barrier 1926 a may be installed at the interface betweenthe internal and external collimators 1920 a,b and otherwise positionedat or near the radial shoulder 2106. The microbial barrier 1926 a may bepresent during the radiation sterilization process. As indicated above,the microbial barrier 1926 a may help seal at least a portion of thesterilization zone 1922. More particularly, the microbial barrier 1926 amay seal off a portion of the sterilization zone 1922 to help form partof a sealed region 2110 configured to isolate the sensor 1816 and thesharp 1818 from external contamination. The sealed region 2110 mayinclude (encompass) select portions of the interior of the electronicshousing 1804 and the sterilization zone 1922. In one or moreembodiments, the sealed region 2110 may be defined and otherwise formedby at least the microbial barrier 1926 a, a first or “top” seal 2112 a,and a second or “bottom” seal 2112 b. The microbial barrier 1926 a andthe top and bottom seals 2112 a,b may each create corresponding barriersat their respective sealing locations, thereby allowing thesterilization zone 1922 containing the sensor 1816 and the sharp 1818 tobe terminally sterilized.

The top seal 2112 a may be arranged to seal the interface between thesharp hub 1820 and the top of the electronics housing 1804 (i.e., theshell 1806 of FIG. 18) and thereby prevent contaminants from migratinginto the interior of the electronics housing 1804. In some embodiments,the top seal 2112 a may form part of the sharp hub 1820, such as beingovermolded onto the sharp hub 1820. In other embodiments, however, thetop seal 2112 a may form part of or be overmolded onto the top surfaceof the shell 1806. In yet other embodiments, the top seal 2112 a maycomprise a separate structure, such as an O-ring or the like, thatinterposes the sharp hub 1820 and the top surface of the shell 1806,without departing from the scope of the disclosure.

The bottom seal 2112 b may comprise the gasket 2016 (FIG. 20C) and, moreparticularly, the annular projection 2020 (FIGS. 20A and 20C) overmoldedonto the applicator insert 1910. In operation, the bottom seal 2112 bmay be arranged to seal the interface between the applicator insert 1910and the bottom of electronics housing 1804 (i.e., the mount 1808 of FIG.18). The bottom seal 2112 b may prevent contaminants from migrating intothe sterilization zone 1922 and from migrating into the interior of theelectronics housing 1804.

Upon loading the sensor control device 1802 into the sensor applicator102 and securing the applicator cap 1904 to the sensor applicator 102,the top and bottom seals 2112 a,b may become progressively compressedand thereby generate corresponding sealed interfaces. The top and bottomseals 2112 a,b may be made of a variety of materials capable ofgenerating a sealed interface between opposing structures. Suitablematerials include, but are not limited to, silicone, a thermoplasticelastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or anycombination thereof.

Once the radiation sterilization process is finished, the externalcollimator 1920 b may be removed from the applicator cap 1904, and themoisture barrier 1926 b may be placed to occlude the opening 1928 in theapplicator cap 1904. Upon delivery, a user may simply remove theapplicator cap 1904 in preparation for delivering the sensor controldevice 1802. In at least one embodiment, removing the applicator cap1904 will simultaneously remove the applicator insert 1910, which may bereceived into the applicator cap 1904 in a manner that allows theapplicator insert 1910 to be secured to the applicator cap 1904 fordisassembly. In such embodiments, for example, the applicator insert1910 may be coupled to the applicator cap 1904 using a snap fitengagement or the like.

In some embodiments, the electronics housing 1804 may be filled with apotting material 2114 that fills in voids within the sensor controldevice 1802. The potting material 2114 may comprise a biocompatiblematerial that meets the requirements of ISO 10993. In some embodiments,for example, the potting material 2114 may comprise a urethane material,such as Resinaid® 3672, or silicone materials, such as SI 5055 or SI5240 available from Henkel®. In other embodiments, the potting material2114 may comprise an acrylate adhesive material, such as GE4949available from Delo®.

The potting material 2114 may also serve as an additional safety barrierfor absorbing or deflecting propagating radiation 2104. In at least oneembodiment, for example, the potting material 2114 may exhibit an e-beamresistance of at least 85 kGy. Accordingly, instead of passing throughair typically present within the electronics housing 1804, the radiation2104 may be required to pass through the potting material 2114 beforeimpinging upon the radiation sensitive component(s) 1908. Although thepotting material 2114 may not comprise a high density material, it maynonetheless serve as another level of radiation shielding. Moreover, thepotting material 2114 may also increase the robustness of the sensorcontrol device 1802 and the electronics housing 1804. Consequently,using the potting material 2114 may allow the electronics hosing 1804 tobe made out of thinner materials, if desired.

It is noted that, while the sensor 1816 and the sharp 1818 extend fromthe bottom of the electronics housing 1804 and into the sterilizationzone 1922 generally concentric with a centerline of the sensorapplicator 102 and the applicator cap 1904, it is contemplated herein tohave an eccentric arrangement. More specifically, in at least oneembodiment, the sensor 1816 and the sharp 1818 may extend from thebottom of the electronics housing 1804 eccentric to the centerline ofthe sensor applicator 102 and the applicator cap 1904. In suchembodiments, the internal and external collimators 1920 a,b may bere-designed and otherwise configured such that the sterilization zone1922 is also eccentrically positioned to receive the sensor 1816 and thesharp 1818, without departing from the scope of the disclosure.

FIGS. 22A and 22B are isometric and cross-sectional side views ofanother embodiment of the applicator insert 1910. The applicator insert1910 depicted in FIGS. 22A-22B may be similar in most respects to theapplicator insert 1910 of FIGS. 20A-20C. Unlike the applicator insert1910 of FIGS. 20A-20C, however, the applicator insert 1910 of FIGS.22A-22B exhibits an eccentric orientation where the internal collimator1920 a is located eccentric to a centerline 2202 (FIG. 22B) of the body2002. In such embodiments, the sensor control device 1802 (FIGS. 19B and21) may also exhibit an eccentric orientation such that the sensor 1816(FIGS. 19B and 21) and the sharp 1818 (FIGS. 19B and 21) are able toextend into the aperture 2005 defined in the top end 2004 a of theapplicator insert 1910. Moreover, in such embodiments, the radialalignment feature 1916, the additional radial alignment features 2006,and the sensor locating features 2012 may prove particularlyadvantageous in helping to properly orient the applicator insert 1910relative to the sensor control device 1802 within the sensor applicator102 (FIGS. 19B and 21).

Embodiments disclosed herein include:

H. A sensor applicator that includes a housing having a sensor controldevice arranged therein, the sensor control device including a sensor, asharp, and a radiation sensitive component, an applicator cap removablycoupled to the housing, an applicator insert positionable within theapplicator cap and defining an internal collimator that receives adistal end of the sensor and the sharp, and an external collimatorextendable into the applicator cap, wherein the internal and externalcollimators cooperatively focus radiation from a radiation sterilizationprocess toward the sensor and the sharp and simultaneously prevent theradiation from damaging the radiation sensitive component.

I. A method of sterilizing a sensor control device that includespositioning the sensor control device within a housing of a sensorapplicator, the sensor control device including a sensor, a sharp, and aradiation sensitive component, receiving a distal end of the sensor andthe sharp within an internal collimator defined by an applicator insert,removably coupling an applicator cap to the housing and thereby securingthe applicator insert within the applicator cap, extending an externalcollimator into the applicator cap and aligning the external collimatorwith the internal collimator, and cooperatively focusing radiation froma radiation sterilization process toward the sensor and the sharp withthe internal and external collimators while simultaneously preventingthe radiation from damaging the radiation sensitive component.

J. A hybrid sterilization assembly that includes an applicator insertpositionable within an applicator cap of a sensor applicator, aninternal collimator defined by the applicator insert to receive a distalend of a sensor and a sharp of a sensor control device arranged within ahousing of the sensor applicator, and an external collimator extendableinto the applicator cap and alignable with the internal collimator,wherein the internal and external collimators cooperatively focusradiation from a radiation sterilization process toward the sensor andthe sharp and simultaneously prevent the radiation from damaging theradiation sensitive component.

Each of embodiments H, I, and J may have one or more of the followingadditional elements in any combination: Element 1: wherein theapplicator insert engages an inner surface of the applicator cap toaxially secure the applicator insert within the applicator cap. Element2: further comprising a sheath extending from the housing and into theapplicator cap when the applicator cap is coupled to the housing, andone or more radial alignment features provided on the applicator insertand matable with one or more corresponding features provided on thesheath to rotationally orient the applicator insert relative to thesensor control device. Element 3: further comprising one or more sensorlocating features provided on the applicator insert and matable with oneor more corresponding features on the sensor control device torotationally orient the applicator insert relative to the sensor controldevice. Element 4: wherein the internal collimator includes acollimating insert and the external collimator is alignable with thecollimating insert. Element 5: wherein the collimating insert and theexternal collimator are each made of a material selected from the groupconsisting of a high-density polymer, a metal, a composite material, andany combination thereof. Element 6: wherein the internal collimatorfurther includes a gasket engageable with a bottom of the sensor controldevice to generate a sealed interface. Element 7: wherein the externalcollimator comprises a cross-sectional shape selected from the groupconsisting of conical, frustoconical, pyramidal, circular, cubic,rectangular, and any combination thereof. Element 8: further comprisinga potting material arranged within the sensor control device.

Element 9: further comprising engaging an inner surface of theapplicator cap against the applicator insert and thereby axiallysecuring the applicator insert within the applicator cap. Element 10:wherein the internal collimator includes a gasket, the method furthercomprising engaging the gasket against a bottom of the sensor controldevice as the applicator insert is axially secured within the applicatorcap, and generating a sealed interface with the gasket against thebottom of the sensor control device. Element 11: wherein the internaland external collimators cooperatively define a sterilization zone thatreceives the sensor and the sharp, the method further comprising sealingat least a portion of the sterilization zone with a microbial barrierpositioned at an interface between the internal and externalcollimators. Element 12: wherein the internal collimator includes acollimating insert and wherein aligning the external collimator with theinternal collimator comprises aligning the external collimator with thecollimating insert. Element 13: wherein the external collimatorcomprises a cross-sectional shape selected from the group consisting ofconical, frustoconical, pyramidal, circular, cubic, rectangular, and anycombination thereof.

Element 14: further comprising a microbial barrier positioned at aninterface between the internal and external collimators. Element 15:wherein the internal collimator includes a collimating insert andwherein the collimating insert and the external collimator are each madeof a material selected from the group consisting of a high-densitypolymer, a metal, a composite material, and any combination thereof.Element 16: wherein the internal collimator further includes a gasketengageable with a bottom of the sensor control device to generate asealed interface. Element 17: wherein the external collimator comprisesa cross-sectional shape selected from the group consisting of conical,frustoconical, pyramidal, circular, cubic, rectangular, and anycombination thereof.

By way of non-limiting example, exemplary combinations applicable to H,I, and J include: Element 4 with Element 5; Element 4 with Element 6;Element 9 with Element 10; and Element 15 with Element 16.

Internal Sterilization Assemblies

Prior to being delivered to an end user, some medical devices must besterilized to render the product free from viable microorganisms. Somemedical devices, however, include under-skin sensing devices or sensorsthat must be sterilized using radiation sterilization, such as electronbeam (“e-beam”) irradiation. Radiation sterilization, however, candamage electronic components associated with the medical device, whichare commonly sterilized via gaseous chemical sterilization (e.g., usingethylene oxide). Gaseous chemical sterilization, however, can damage theenzymes or other chemistry and biologics included on the under-skinsensing devices.

In the past, this sterilization incompatibility has been circumvented byseparating the under-skin sensing devices and the electronic componentsand sterilizing each individually. This approach, however, requiresadditional parts, packaging, process steps, and final assembly by theuser, which introduces a possibility of user error. According to thepresent disclosure, any device requiring terminal sterilization, may beproperly sterilized using an internal sterilization assembly designed tofocus sterilizing radiation (e.g., beams, waves, energy, etc.) towardcomponent parts requiring sterilization, while simultaneously preventingthe propagating radiation from disrupting or damaging sensitiveelectronic components.

FIG. 23 is a schematic diagram of an example internal sterilizationassembly 2300, according to one or more embodiments of the presentdisclosure. The internal sterilization assembly 2300 (hereafter the“assembly 2300”) may be designed and otherwise configured to helpsterilize a medical device 2302. The medical device 2302 may comprise atype of a health care product including any device, mechanism, assembly,or system requiring terminal sterilization of one or more componentparts. Suitable examples of the medical device 2302 include, but are notlimited to, ingestible products, cardiac rhythm management (CRM)devices, under-skin sensing devices, externally mounted medical devices,medication delivery devices, or any combination thereof.

In the illustrated embodiment, the medical device 2302 comprises anunder-skin sensing device or “sensor control device,” also referred toas an “in vivo analyte sensor control device”. As illustrated, themedical device 2302 may be housed within a sensor applicator 2304(alternately referred to as an “inserter”) and a cap 2306 may beremovably coupled to the sensor applicator 2304. The medical device 2302includes a housing 2308, a part 2310 requiring sterilization, and one ormore radiation sensitive components 2312. In some embodiments, the part2310 may comprise a sensor that extends from the housing 2308. In atleast one embodiment, the part 2310 may further include a sharp that mayalso require sterilization and may help implant the sensor beneath theskin of a user. As illustrated, the part 2310 may extend at an anglefrom the bottom of the housing 2308, but could alternatively extendperpendicularly from the bottom or from another surface of the housing2308. Moreover, as illustrated, the part 2310 may extend from one end ofthe housing 2308 or otherwise offset from a centerline of the housing2308, but may alternatively extend concentric with the housing, withoutdeparting from the scope of the disclosure.

The sensor applicator 2304 is used to deliver the medical device 2302 toa target monitoring location on a user's skin (e.g., the arm of theuser). In some embodiments, the cap 2306 may be threaded to the sensorapplicator 2304 and removed from the sensor applicator 2304 byunscrewing the cap 2306 from engagement with the sensor applicator 2304.Once the cap 2306 is removed, a user may then use the sensor applicator2304 to position the medical device 2302 at a target monitoring locationon the user's body. The part 2310 is positioned such that it can betranscutaneously positioned and otherwise retained under the surface ofthe user's skin. In some embodiments, the medical device 2302 may bespring loaded for ejection from the sensor applicator 2304. Oncedelivered, the medical device 2302 may be maintained in position on theskin with an adhesive patch (not shown) coupled to the bottom of themedical device 2302.

In the illustrated embodiment, the radiation sensitive component 2312may be mounted to a printed circuit board (PCB) 2314 positioned withinthe housing 2308. The radiation sensitive component 2312 may include oneor more electronic modules such as, but not limited to, a dataprocessing unit (e.g., an application specific integrated circuit or“ASIC”), a resistor, a transistor, a capacitor, an inductor, a diode, aswitch, or any combination thereof. In other embodiments, however, theradiation sensitive component 2312 may comprise a radiation sensitivechemical solution or analyte (e.g., an active agent, pharmaceutical,biologic, etc.). In such embodiments, the medical device 2302 mayalternatively comprise a hypodermic needle or syringe and the chemicalsolution or analyte may be positioned within an ampoule of the medicaldevice 2302.

The medical device 2302 may be subjected to radiation sterilization 2316to properly sterilize the part 2310 for use. Suitable radiationsterilization 2316 processes include, but are not limited to, electronbeam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, orany combination thereof. The cap 2306 may define a collimator 2318 thatallows the radiation 2316 to impinge upon and sterilize the part 2310.The cap 2306, however, may also act as a radiation shield that helpsprevent (impede) propagating radiation 2316 from disrupting or damagingthe radiation sensitive component(s) 2312. To accomplish this, the cap2306 may be made of a material that reduces or prevents the radiation2316 from penetrating therethrough.

More specifically, the cap 2306 may be made of a material having adensity sufficient to absorb the dose of the radiation 2316 beam energybeing delivered. In some embodiments, for example, the cap 2306 may bemade of any material that has a mass density greater than 0.9 grams percubic centimeter (g/cc). In other embodiments, however, the mass densityof a suitable material may be less than 0.9 g/cc, without departing fromthe scope of the disclosure. Suitable materials for the cap 2306include, but are not limited to, a high-density polymer, (e.g.,polyethylene, polypropylene, polystyrene, polytetrafluoroethylene,etc.), a metal (e.g., lead, stainless steel, aluminum, etc.), anycombination thereof, or any material having a mass density greater than0.9 g/cc.

As illustrated, the collimator 2318 generally comprises a hole orpassageway extending at least partially through the cap 2306. Thecollimator 2318 defines a sterilization zone 2320 configured to focusthe radiation 2316 toward the part 2310. In the illustrated embodiment,the part 2310 may be received within the sterilization zone 2320 forsterilization. The collimator 2318 can exhibit any suitablecross-sectional shape necessary to focus the radiation 2316 on the part2310 for sterilization. In the illustrated embodiment, for example, thecollimator 2318 exhibits a circular cross-sectional shape with parallelsides. In other embodiments, however, the collimator 2318 may exhibit apolygonal cross-sectional shape, such as cubic or rectangular (e.g.,including parallelogram), without departing from the scope of thedisclosure.

In the illustrated embodiment, the collimator 2318 provides a firstaperture 2322 a and a second aperture 2322 b where the first and secondapertures 2322 a,b are defined at opposing ends of the sterilizationzone 2320. The first aperture 2322 a may allow the radiation 2316 toenter the sterilization zone 2320 and impinge upon the part 2310, andthe second aperture 2322 b may be configured to receive the part 2310into the sterilization zone 2320. In embodiments where the collimator2318 is cylindrical in shape, the first and second apertures 2322 a,bexhibit identical diameters.

In some embodiments, a cap seal 2324 (shown in dashed lines) may bepositioned at the opening of the collimator 2318 and otherwise at thefirst aperture 2322 a. The cap seal 2324 may comprise a radiationpermeable, microbial barrier. In some embodiments, for example, the capseal 2324 may be made of a synthetic material (e.g., a flash-spunhigh-density polyethylene fiber), such as TYVEK® available from DuPont®.In other embodiments, however, the cap seal 2324 may comprise, but it nolimited to, tape, paper, foil, or any combination thereof. In yet otherembodiments, the cap seal 2324 may comprise a thinned portion of the cap2306, without departing from the scope of the disclosure. In suchembodiments, the first aperture 2322 a would be omitted.

The cap seal 2324 may seal off a portion of the sterilization zone 2320to isolate the part 2310 from external contamination, whilesimultaneously allowing the radiation 2316 to pass therethrough tosterilize the part 2310. In some embodiments, a desiccant (not shown)may be arranged within the sterilization zone 2320.

In some embodiments, the assembly 2300 may further include a barriershield 2326 positioned within the housing 2308. The barrier shield 2326may be configured to help block radiation 2316 (e.g., electrons) frompropagating within the housing 2308 toward the radiation sensitivecomponent(s) 2312. The barrier shield 2326 may be made of any of thematerials mentioned above for the cap 2306. In the illustratedembodiment, the barrier shield 2326 is positioned vertically within thehousing 2308, but may alternatively be positioned at any other angularconfiguration suitable for protecting the radiation sensitivecomponent(s) 2312.

FIG. 24 is a schematic diagram of another example internal sterilizationassembly 2400, according to one or more additional embodiments of thepresent disclosure. The internal sterilization assembly 2400 (hereafterthe “assembly 2400”) may be similar in some respects to the assembly2300 of FIG. 23 and therefore may be best understood with referencethereto, where like numeral represent like components not describedagain in detail. Similar to the assembly 2300 of FIG. 23, for example,the assembly 2400 may be designed and otherwise configured to helpsterilize a medical device 2402, which may be similar to the medicaldevice 2302 of FIG. 23. The medical device 2402 may comprise a sensorcontrol device similar to the medical device 2302 of FIG. 23, but mayalternatively comprise any of the health care products mentioned herein.

As illustrated, the medical device 2402 may be housed within a sensorapplicator 2404 and, more specifically, within a pocket 2406 defined inthe sensor applicator 2404. In some embodiments, a desiccant (not shown)may be arranged within the pocket 2406. Similar to the medical device2302 of FIG. 23, the medical device 2402 may include the housing 2308,the part 2310 requiring sterilization, and the radiation sensitivecomponent(s) 2312. In some embodiments, the assembly 2400 may furtherinclude the barrier shield 2326, as generally described above. Asillustrated, the part 2310 may extend perpendicularly from the bottom ofthe housing 2308, but could alternatively extend at an angle or fromanother surface. Moreover, as illustrated, the part 2310 may extendalong a centerline of the housing 2308, but may alternatively extendeccentric to the centerline, without departing from the scope of thedisclosure.

The sensor applicator 2404 is used to deliver the medical device 2402 toa target monitoring location on a user's skin (e.g., the arm of theuser). As illustrated, the sensor applicator 2404 may include aspring-loaded button 2408 at least partially received within the sensorapplicator 2404. The button 2408 extends within a channel 2409 definedin the sensor applicator 2404 and is engageable with the top of thehousing 2308 at its bottom end. In at least one embodiment, a sealedinterface is created where the bottom of the button 2406 engages thehousing 2308. The medical device 2402 may be deployed for use from thepocket 2406 by pressing down on the button 2408, which acts on thehousing 2308 and thereby pushes the medical device 2402 distally and outof the pocket 2406 and away from the sensor applicator 2404. The part2310 is positioned such that it can be transcutaneously positioned andotherwise retained under the surface of the user's skin. Once delivered,the medical device 2402 may be maintained in position on the skin withan adhesive patch (not shown) coupled to the bottom of the medicaldevice 2402.

The medical device 2402 may be subjected to radiation sterilization 2316to properly sterilize the part 2310 prior to use. In the illustratedembodiment, the radiation sterilization 2316 is directed to the top ofthe sensor applicator 2404 and the button 2408 defines a collimator 2410that allows the radiation 2316 to impinge upon and sterilize the part2310. As illustrated, the collimator 2410 generally comprises a hole orpassageway extending at least partially through the button 2408. Thecollimator 2410 focuses the radiation 2316 toward the part 2310 and canexhibit any suitable cross-sectional shape necessary to focus theradiation 2316 on the part 2310 for sterilization. In the illustratedembodiment, for example, the collimator 2410 exhibits a circularcross-section with parallel sides. In other embodiments, however, thecollimator 2410 may exhibit a polygonal cross-sectional shape, such ascubic or rectangular (e.g., including parallelogram), without departingfrom the scope of the disclosure.

Portions of the sensor applicator 2404 and the button 2408, however, mayalso act as a radiation shield that helps prevent (impede) propagatingradiation 2316 from disrupting or damaging the radiation sensitivecomponent(s) 2312, except through the collimator 2410. To accomplishthis, the sensor applicator 2404 and the button 2408 may be made of amaterial similar to the material of the cap 2306 of FIG. 23. In at leastone embodiment, the radiation sterilization 2316 may be emitted from adevice or machine configured to focus and/or aim the radiation 2316directly into the collimator 2410, and thereby mitigating radiation 2316exposure to adjacent portions of the sensor applicator 2404.

In some embodiments, a first seal 2412 a (shown in dashed lines) may bepositioned at the opening of the pocket 2406, and a second seal 2412 bmay be arranged at the opening to the collimator 2410 at the top of thebutton 2406. The seals 2412 a,b may comprise radiation permeable,microbial barriers, similar to the cap seal 2324 of FIG. 23. The firstseal 2412 a may seal off the pocket 2406 on the bottom of the sensorapplicator 2404 to isolate the part 2310 from external contamination,and the second seal 2412 b may seal off the collimator 2410, whilesimultaneously allowing the radiation 2316 to pass therethrough tosterilize the part 2310.

FIG. 25 is a schematic diagram of another example internal sterilizationassembly 2500, according to one or more additional embodiments of thepresent disclosure. The internal sterilization assembly 2500 (hereafterthe “assembly 2500”) may be similar in some respects to the assemblies2300 and 2400 of FIGS. 23 and 24 and therefore may be best understoodwith reference thereto, where like numeral represent like components notdescribed again in detail. Similar to the assemblies 2300 and 2400 ofFIGS. 23 and 24, for example, the assembly 2500 may be designed andotherwise configured to help sterilize a medical device 2502, which maybe similar to the medical devices 2302 and 2402 of FIGS. 23 and 24. Themedical device 2502 may comprise a sensor control device similar to themedical devices 2302 and 2402 of FIGS. 23 and 24, but may alternativelycomprise any of the health care products mentioned herein.

As illustrated, the medical device 2502 may be housed within a sensorapplicator 2504, which may include a spring-loaded sheath 2506. Themedical device 2502 may be positioned within a pocket 2508 defined atleast partially by the sheath 2506. In some embodiments, a desiccant(not shown) may be arranged within the pocket 2508. Similar to themedical devices 2302 and 2402 of FIGS. 23 and 24, the medical device2502 may include the housing 2308, the part 2310 requiringsterilization, and the radiation sensitive component(s) 2312. In someembodiments, the assembly 2500 may further include the barrier shield2326, as generally described above.

As illustrated, the part 2310 may extend perpendicularly from the bottomof the housing 2308, but could alternatively extend at an angle or fromanother surface. Moreover, as illustrated, the part 2310 may extendalong a centerline of the housing 2308, but may alternatively extendeccentric to the centerline, without departing from the scope of thedisclosure.

The sensor applicator 2504 is used to deliver the medical device 2502 toa target monitoring location on a user's skin (e.g., the arm of theuser). The medical device 2502 may be deployed for use from the pocket2508 by forcing the sheath 2506 against the user's skin and therebycausing the sheath 2506 to collapse into the body of the sensorapplicator 2504. Once the sheath 2506 collapses past the housing 2308,the medical device 2502 may be discharged from the sensor applicator2504. The part 2310 is positioned such that it can be transcutaneouslypositioned and otherwise retained under the surface of the user's skin.Once delivered, the medical device 2502 may be maintained in position onthe skin with an adhesive patch (not shown) coupled to the bottom of themedical device 2502. \

The medical device 2502 may be subjected to radiation sterilization 2316to properly sterilize the part 2310 prior to use. In the illustratedembodiment, the radiation sterilization 2316 is directed to the top ofthe sensor applicator 2504, which defines a collimator 2510 that allowsthe radiation 2316 to impinge upon and sterilize the part 2310. Asillustrated, the collimator 2510 generally comprises a hole orpassageway extending through the body of the sensor applicator 2504. Thecollimator 2510 focuses the radiation 2316 toward the part 2310 and canexhibit any suitable cross-sectional shape necessary to focus theradiation 2316 on the part 2310 for sterilization. In the illustratedembodiment, for example, the collimator 2510 exhibits a circularcross-sectional shape with parallel sides. In other embodiments,however, the collimator 2510 may exhibit a polygonal cross-sectionalshape, such as cubic or rectangular (e.g., including parallelogram),without departing from the scope of the disclosure.

The sensor applicator 2504, however, may also act as a radiation shieldthat helps prevent (impede) propagating radiation 2316 from disruptingor damaging the radiation sensitive component(s) 2312, except throughthe collimator 2510. To accomplish this, the sensor applicator 2504 maybe made of a material similar to the material of the cap 2306 of FIG.23. In at least one embodiment, however, the radiation sterilization2316 may be emitted from a device or machine configured to focus and/oraim the radiation 2316 directly into the collimator 2510, and therebymitigating radiation 2316 exposure to adjacent portions of the sensorapplicator 2504.

In some embodiments, a first seal 2512 a (shown in dashed lines) may bepositioned at the opening of the pocket 2508, and a second seal 2512 bmay be arranged at the opening to the collimator 2510 at the top of thesensor applicator 2504. The seals 2512 a,b may comprise radiationpermeable, microbial barriers, similar to the cap seal 2324 of FIG. 23.The first seal 2512 a may seal off the pocket 2508 on the bottom of thesensor applicator 2504 to isolate the part 2310 from externalcontamination, and the second seal 2512 b may seal off the collimator2510, while simultaneously allowing the radiation 2316 to passtherethrough to sterilize the part 2310.

Embodiments disclosed herein include:

K. An internal sterilization assembly that includes a sensor applicator,a medical device at least partially housed within the sensor applicatorand having a part requiring sterilization and a radiation sensitivecomponent, and a cap removably coupled to the sensor applicator andproviding a collimator alignable with the part requiring sterilization,wherein the collimator focuses radiation from a radiation sterilizationprocess toward the part requiring sterilization and the radiation isprevented from damaging the radiation sensitive component.

Embodiment K may have one or more of the following additional elementsin any combination: Element 1: wherein the radiation sensitive componentis selected from the group consisting of an electronic module, achemical solution, and any combination thereof. Element 2: wherein thecollimator comprises a cross-sectional shape selected from the groupconsisting of circular, cubic, rectangular, and any combination thereof.Element 3: wherein the medical device comprises an in vivo analytesensor control device and the part requiring sterilization comprises atleast one of a sensor and a sharp extending from the housing of the invivo analyte sensor control device. Element 4: wherein the at least oneof the sensor and the sharp extends at an angle from the bottom of thehousing. Element 5: wherein the at least one of the sensor and the sharpextends perpendicularly from the bottom of the housing. Element 6:wherein the at least one of the sensor and the sharp extends from thebottom of the housing along a centerline of the housing. Element 7:wherein the at least one of the sensor and the sharp extends from thebottom of the housing offset from a centerline of the housing. Element8: wherein the cap is made of a material having a mass density greaterthan 0.9 g/cc. Element 9: wherein the cap is made of a material selectedfrom the group consisting of a high-density polymer, a metal, and anycombination thereof. Element 10: wherein the medical device comprises anin vivo analyte sensor control device having a housing that houses theradiation sensitive component, the internal sterilization assemblyfurther comprising a barrier shield positioned within the housing toblock the radiation from propagating within the housing toward theradiation sensitive component. Element 11: further comprising aspring-loaded button at least partially received within the sensorapplicator and engageable with a top of the medical device, wherein thecollimator is defined through the button. Element 12: further comprisinga sealed interface at the intersection of the button and the medicaldevice. Element 13: wherein at least one of the button and the sensorapplicator is made of a material selected from the group consisting of ahigh-density polymer, a metal, and any combination thereof. Element 14:wherein the sensor applicator includes a spring-loaded sheath and themedical device is housed within a pocket at least partially defined bythe sheath. Element 15: wherein the collimator is defined through thesensor applicator.

By way of non-limiting example, exemplary combinations applicable to A,B, and C include: Element 3 with Element 4; Element 3 with Element 5;Element 3 with Element 6; Element 3 with Element 7; Element 8 withElement 9; Element 11 with Element 12; Element 11 with Element 13; andElement 14 with Element 15.

One-Piece Bio-Sensor Design with Sensor Preservation Vial

FIGS. 26A and 26B are isometric and side views, respectively, of anexample sensor control device 2602, according to one or more embodimentsof the present disclosure. The sensor control device 2602 (alternatelyreferred to as a “puck”) may be similar in some respects to the sensorcontrol device 104 of FIG. 1 and therefore may be best understood withreference thereto. The sensor control device 2602 may replace the sensorcontrol device 104 of FIG. 1 and, therefore, may be used in conjunctionwith the sensor applicator 102 (FIG. 1), which delivers the sensorcontrol device 2602 to a target monitoring location on a user's skin.

The sensor control device 2602, however, may be incorporated into aone-piece system architecture in contrast to the sensor control device104 of FIG. 1. Unlike the two-piece architecture, for example, a user isnot required to open multiple packages and finally assemble the sensorcontrol device 2602. Rather, upon receipt by the user, the sensorcontrol device 2602 is already fully assembled and properly positionedwithin the sensor applicator 102 (FIG. 1). To use the sensor controldevice 2602, the user need only open one barrier (e.g., the applicatorcap 210 of FIG. 2B) before promptly delivering the sensor control device2602 to the target monitoring location.

As illustrated, the sensor control device 2602 includes an electronicshousing 2604 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing2604 may exhibit other cross-sectional shapes, such as ovoid orpolygonal, without departing from the scope of the disclosure. Theelectronics housing 2604 may be configured to house or otherwise containvarious electrical components used to operate the sensor control device2602.

The electronics housing 2604 may include a shell 2606 and a mount 2608that is matable with the shell 2606. The shell 2606 may be secured tothe mount 2608 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, or one or more mechanical fasteners(e.g., screws). In some cases, the shell 2606 may be secured to themount 2608 such that a sealed interface therebetween is generated. Insuch embodiments, a gasket or other type of seal material may bepositioned at or near the outer diameter (periphery) of the shell 2606and the mount 2608, and securing the two components together maycompress the gasket and thereby generate a sealed interface. In otherembodiments, an adhesive may be applied to the outer diameter(periphery) of one or both of the shell 2606 and the mount 2608. Theadhesive secures the shell 2606 to the mount 2608 and providesstructural integrity, but may also seal the interface between the twocomponents and thereby isolate the interior of the electronics housing2604 from outside contamination. If the sensor control device 2602 isassembled in a controlled environment, there may be no need toterminally sterilize the internal electrical components. Rather, theadhesive coupling may provide a sufficient sterile barrier for theassembled electronics housing 2604.

The sensor control device 2602 may further include a plug assembly 2610that may be coupled to the electronics housing 2604. The plug assembly2610 may be similar in some respects to the plug assembly 207 of FIG.2A. For example, the plug assembly 2610 may include a sensor module 2612(partially visible) interconnectable with a sharp module 2614 (partiallyvisible). The sensor module 2612 may be configured to carry andotherwise include a sensor 2616 (partially visible), and the sharpmodule 2614 may be configured to carry and otherwise include a sharp2618 (partially visible) used to help deliver the sensor 2616transcutaneously under a user's skin during application of the sensorcontrol device 2602. As illustrated, corresponding portions of thesensor 2616 and the sharp 2618 extend from the electronics housing 2604and, more particularly, from the bottom of the mount 2608. The exposedportion of the sensor 2616 may be received within a hollow or recessedportion of the sharp 2618. The remaining portion of the sensor 2616 ispositioned within the interior of the electronics housing 2604.

As discussed in more detail below, the sensor control device 2602 mayfurther include a sensor preservation vial 2620 that provides apreservation barrier surrounding and protecting the exposed portions ofthe sensor 2616 and the sharp 2618 from gaseous chemical sterilization.

FIGS. 27A and 27B are isometric and exploded views, respectively, of theplug assembly 2610, according to one or more embodiments. The sensormodule 2612 may include the sensor 2616, a plug 2702, and a connector2704. The plug 2702 may be designed to receive and support both thesensor 2616 and the connector 2704. As illustrated, a channel 2706 maybe defined through the plug 2702 to receive a portion of the sensor2616. Moreover, the plug 2702 may provide one or more deflectable arms2707 configured to snap into corresponding features provided on thebottom of the electronics housing 2604 (FIGS. 26A-26B).

The sensor 2616 includes a tail 2708, a flag 2710, and a neck 2712 thatinterconnects the tail 2708 and the flag 2710. The tail 2708 may beconfigured to extend at least partially through the channel 2706 andextend distally from the plug 2702. The tail 2708 includes an enzyme orother chemistry or biologic and, in some embodiments, a membrane maycover the chemistry. In use, the tail 2708 is transcutaneously receivedbeneath a user's skin, and the chemistry included thereon helpsfacilitate analyte monitoring in the presence of bodily fluids.

The flag 2710 may comprise a generally planar surface having one or moresensor contacts 2714 (three shown in FIG. 27B) arranged thereon. Thesensor contact(s) 2714 may be configured to align with a correspondingnumber of compliant carbon impregnated polymer modules (tops of whichshown at 2720) encapsulated within the connector 2704.

The connector 2704 includes one or more hinges 2718 that enables theconnector 2704 to move between open and closed states. The connector2704 is depicted in FIGS. 27A-27B in the closed state, but can pivot tothe open state to receive the flag 2710 and the compliant carbonimpregnated polymer module(s) therein. The compliant carbon impregnatedpolymer module(s) provide electrical contacts 2720 (three shown)configured to provide conductive communication between the sensor 2616and corresponding circuitry contacts provided within the electricalhousing 2604 (FIGS. 26A-26B). The connector 2704 can be made of siliconerubber and may serve as a moisture barrier for the sensor 2616 whenassembled in a compressed state and after application to a user's skin.

The sharp module 2614 includes the sharp 2618 and a sharp hub 2722 thatcarries the sharp 2618. The sharp 2618 includes an elongate shaft 2724and a sharp tip 2726 at the distal end of the shaft 2724. The shaft 2724may be configured to extend through the channel 2706 and extend distallyfrom the plug 2702. Moreover, the shaft 2724 may include a hollow orrecessed portion 2728 that at least partially circumscribes the tail2708 of the sensor 2616. The sharp tip 2726 may be configured topenetrate the skin while carrying the tail 2708 to put the activechemistry present on the tail 2708 into contact with bodily fluids.

The sharp hub 2722 may include a hub small cylinder 2730 and a hub snappawl 2732, each of which may be configured to help couple the plugassembly 2610 (and the entire sensor control device 2602) to the sensorapplicator 102 (FIG. 1).

With specific reference to FIG. 27B, the preservation vial 2620 maycomprise a generally cylindrical and elongate body 2734 having a firstend 2736 a and a second end 2736 b opposite the first end 2736 a. Thefirst end 2736 a may be open to provide access into an inner chamber2738 defined within the body 2734. In contrast, the second end 2736 bmay be closed and may provide or otherwise define an enlarged head 2740.The enlarged head 2740 exhibits an outer diameter that is greater thanthe outer diameter of the remaining portions of the body 2734. In otherembodiments, however, the enlarged head 2740 may be positioned at anintermediate location between the first and second ends 2736 a,b.

FIG. 27C is an exploded isometric bottom view of the plug 2702 and thepreservation vial 2620. As illustrated, the plug 2702 may define anaperture 2742 configured to receive the preservation vial 2620 and, moreparticularly, the first end 2736 a of the body 2734. The channel 2706may terminate at the aperture 2742 such that components extending out ofand distally from the channel 2706 will be received into the innerchamber 2738 when the preservation vial 2620 is coupled to the plug2702.

The preservation vial 2620 may be removably coupled to the plug 2702 atthe aperture 2742. In some embodiments, for example, the preservationvial 2620 may be received into the aperture 2742 via an interference orfriction fit. In other embodiments, the preservation vial 2620 may besecured within the aperture 2742 with a frangible member (e.g., a shearring) or substance that may be broken with minimal separation force. Insuch embodiments, for example, the preservation vial 2620 may be securedwithin the aperture 2742 with a tag (spot) of glue, a dab of wax, or thepreservation vial 2620 may include an easily peeled off glue. Asdescribed below, the preservation vial 2620 may be separated from theplug 2702 prior to delivering the sensor control device 2602 (FIGS.26A-26B) to the target monitoring location on the user's skin.

Referring again to FIGS. 27A and 27B, the inner chamber 2738 may besized and otherwise configured to receive the tail 2708, a distalsection of the shaft 2724, and the sharp tip 2726, collectively referredto as the “distal portions of the sensor 2616 and the sharp 2618.” Theinner chamber 2738 may be sealed or otherwise isolated to preventsubstances that might adversely interact with the chemistry of thesensor 2616 from migrating into the inner chamber 2738. Morespecifically, the inner chamber 2728 may be sealed to protect or isolatethe distal portions of the sensor 2616 and the sharp 2618 during agaseous chemical sterilization process since gases used during gaseouschemical sterilization can adversely affect the enzymes (and othersensor components, such as membrane coatings that regulate analyteinflux) provided on the tail 2708.

In some embodiments, a seal 2744 (FIG. 27B) may provide a sealed barrierbetween the inner chamber 2738 and the exterior environment. In at leastone embodiment, the seal 2744 may be arranged within the inner chamber2738, but could alternatively be positioned external to the body 2734,without departing from the scope of the disclosure. The distal portionsof the sensor 2616 and the sharp 2618 may penetrate the seal 2744 andextend into the inner chamber 2738, but the seal 2744 may maintain asealed interface about the distal portions of the sensor 2616 and thesharp 2618 to prevent migration of contaminants into the inner chamber2738. The seal 2744 may be made of, for example, a pliable elastomer ora wax.

In other embodiments (or in addition to the seal 2744), a sensorpreservation fluid 2746 (FIG. 27B) may be present within the innerchamber 2738 and the distal portions of the sensor 2616 and the sharp2618 may be immersed in or otherwise encapsulated by the preservationfluid 2746. The preservation fluid 2746 may generate a sealed interfacethat prevents sterilization gases from interacting with the enzymesprovided on the tail 2708.

The plug assembly 2610 may be subjected to radiation sterilization toproperly sterilize the sensor 2616 and the sharp 2618. Suitableradiation sterilization processes include, but are not limited to,electron beam (e-beam) irradiation, gamma ray irradiation, X-rayirradiation, or any combination thereof. In some embodiments, the plugassembly 2610 may be subjected to radiation sterilization prior tocoupling the preservation vial 2620 to the plug 2702. In otherembodiments, however, the plug assembly 2610 may sterilized aftercoupling the preservation vial 2620 to the plug 2702. In suchembodiments, the body 2734 of the preservation vial 2620 and thepreservation fluid 2746 may comprise materials and/or substances thatpermit the propagation of radiation therethrough to facilitate radiationsterilization of the distal portions of the sensor 2616 and the sharp2618.

Suitable materials for the body 2734 include, but are not limited to, anon-magnetic metal (e.g., aluminum, copper, gold, silver, etc.), athermoplastic, ceramic, rubber (e.g., ebonite), a composite material(e.g., fiberglass, carbon fiber reinforced polymer, etc.), an epoxy, orany combination thereof. In some embodiments, the material for the body2734 may be transparent or translucent, but can otherwise be opaque,without departing from the scope of the disclosure.

The preservation fluid 2746 may comprise any inert and biocompatiblefluid (i.e., liquid, gas, gel, wax, or any combination thereof) capableof encapsulating the distal portions of the sensor 2616 and the sharp2618. In some embodiments, the preservation fluid 2746 may also permitthe propagation of radiation therethrough. The preservation fluid 2746may comprise a fluid that is insoluble with the chemicals involved ingaseous chemical sterilization. Suitable examples of the preservationfluid 2746 include, but are not limited to, silicone oil, mineral oil, agel (e.g., petroleum jelly), a wax, fresh water, salt water, a syntheticfluid, glycerol, sorbitan esters, or any combination thereof. As will beappreciated, gels and fluids that are more viscous may be preferred sothat the preservation fluid 2746 does not flow easily.

In some embodiments, the preservation fluid 2746 may include ananti-inflammatory agent, such as nitric oxide or another knownanti-inflammatory agent. The anti-inflammatory agent may proveadvantageous in minimizing local inflammatory response caused bypenetration of the sharp 2618 and the sensor 2616 into the skin of theuser. It has been observed that inflammation can affect the accuracy ofglucose readings, and by including the anti-inflammatory agent thehealing process may be accelerated, which may result in obtainingaccurate readings more quickly.

FIGS. 28A and 28B are exploded and bottom isometric views, respectively,of the electronics housing 2604, according to one or more embodiments.The shell 2606 and the mount 2608 operate as opposing clamshell halvesthat enclose or otherwise substantially encapsulate the variouselectronic components of the sensor control device 2602 (FIGS. 26A-26B).

A printed circuit board (PCB) 2802 may be positioned within theelectronics housing 2604. A plurality of electronic modules (not shown)may be mounted to the PCB 2802 including, but not limited to, a dataprocessing unit, resistors, transistors, capacitors, inductors, diodes,and switches. The data processing unit may comprise, for example, anapplication specific integrated circuit (ASIC) configured to implementone or more functions or routines associated with operation of thesensor control device 2602. More specifically, the data processing unitmay be configured to perform data processing functions, where suchfunctions may include but are not limited to, filtering and encoding ofdata signals, each of which corresponds to a sampled analyte level ofthe user. The data processing unit may also include or otherwisecommunicate with an antenna for communicating with the reader device 106(FIG. 1).

As illustrated, the shell 2606, the mount 2608, and the PCB 2802 eachdefine corresponding central apertures 2804, 2806, and 2808,respectively. When the electronics housing 2604 is assembled, thecentral apertures 2804, 2806, 2808 coaxially align to receive the plugassembly 2610 (FIGS. 27A-27B) therethrough. A battery 2810 may also behoused within the electronics housing 2604 and configured to power thesensor control device 2602.

In FIG. 28B, a plug receptacle 2812 may be defined in the bottom of themount 2808 and provide a location where the plug assembly 2610 (FIGS.27A-27B) may be received and coupled to the electronics housing 2604,and thereby fully assemble the sensor control device 2602 (FIG. 26A-3B).The profile of the plug 2702 (FIGS. 27A-27C) may match or be shaped incomplementary fashion to the plug receptacle 2812, and the plugreceptacle 2812 may provide one or more snap ledges 2814 (two shown)configured to interface with and receive the deflectable arms 2707(FIGS. 27A-27B) of the plug 2702. The plug assembly 2610 is coupled tothe electronics housing 2604 by advancing the plug 2702 into the plugreceptacle 2812 and allowing the deflectable arms 2707 to lock into thecorresponding snap ledges 2814. When the plug assembly 2610 (FIGS.27A-27B) is properly coupled to the electronics housing 2604, one ormore circuitry contacts 2816 (three shown) defined on the underside ofthe PCB 2802 may make conductive communication with the electricalcontacts 2720 (FIGS. 27A-27B) of the connector 2704 (FIGS. 27A-27B).

FIGS. 29A and 29B are side and cross-sectional side views, respectively,of an example embodiment of the sensor applicator 102 with theapplicator cap 210 coupled thereto. More specifically, FIGS. 29A-29Bdepict how the sensor applicator 102 might be shipped to and received bya user. According to the present disclosure, and as seen in FIG. 29B,the sensor control device 2602 is already assembled and installed withinthe sensor applicator 102 prior to being delivered to the user.

As indicated above, prior to coupling the plug assembly 2610 to theelectronics housing 2604, the plug assembly 2610 may be subjected toradiation sterilization to sterilize the distal portions of the sensor2616 and the sharp 2618. Once properly sterilized, the plug assembly2610 may then be coupled to the electronics housing 2604, as generallydescribed above, and thereby form the fully assembled sensor controldevice 2602. The sensor control device 2602 may then be loaded into thesensor applicator 102, and the applicator cap 210 may be coupled to thesensor applicator 102. The applicator cap 210 may be threaded to thehousing 208 and include a tamper ring 2902. Upon rotating (e.g.,unscrewing) the applicator cap 210 relative to the housing 208, thetamper ring 2902 may shear and thereby free the applicator cap 210 fromthe sensor applicator 102.

According to the present disclosure, while loaded in the sensorapplicator 102, the sensor control device 2602 may be subjected togaseous chemical sterilization 2904 configured to sterilize theelectronics housing 2604 and any other exposed portions of the sensorcontrol device 2602. To accomplish this, a chemical may be injected intoa sterilization chamber 2906 cooperatively defined by the sensorapplicator 102 and the interconnected cap 210. In some applications, thechemical may be injected into the sterilization chamber 2906 via one ormore vents 2908 defined in the applicator cap 210 at its proximal end2910. Example chemicals that may be used for the gaseous chemicalsterilization 2904 include, but are not limited to, ethylene oxide,vaporized hydrogen peroxide, and nitrogen oxide (e.g., nitrous oxide,nitrogen dioxide, etc.).

Since the distal portions of the sensor 2616 and the sharp 2618 aresealed within the preservation vial 2620, the chemicals used during thegaseous chemical sterilization process do not interact with the enzymes,chemistry or biologics provided on the tail 2708.

Once a desired sterility assurance level has been achieved within thesterilization chamber 2906, the gaseous solution is removed and thesterilization chamber 2906 is aerated. Aeration may be achieved by aseries of vacuums and subsequently circulating nitrogen gas or filteredair through the sterilization chamber 2906. Once the sterilizationchamber 2906 is properly aerated, the vents 2908 may be occluded with aseal 2912 (shown in dashed lines).

In some embodiments, the seal 2912 may comprise two or more layers ofdifferent materials. The first layer may be made of a synthetic material(e.g., a flash-spun high-density polyethylene fiber), such as Tyvek®available from DuPont®. Tyvek® is highly durable and puncture resistantand allows the permeation of vapors. The Tyvek® layer can be appliedbefore the gaseous chemical sterilization process, and following thegaseous chemical sterilization process, a foil or other vapor andmoisture resistant material layer may be sealed (e.g., heat sealed) overthe Tyvek® layer to prevent the ingress of contaminants and moistureinto the sterilization chamber 2906. In other embodiments, the seal 2912may comprise only a single protective layer applied to the applicatorcap 210. In such embodiments, the single layer is gas permeable for thesterilization process, but is also capable of protection againstmoisture and other harmful elements once the sterilization process iscomplete.

With the seal 2912 in place, the applicator cap 210 provides a barrieragainst outside contamination, and thereby maintains a sterileenvironment for the assembled sensor control device 2602 until the userremoves (unthreads) the applicator cap 210. The applicator cap 210 mayalso create a dust-free environment during shipping and storage thatprevents an adhesive patch 2914 used to secure the sensor control device2602 to the user's skin from becoming dirty.

FIG. 30 is a perspective view of an example embodiment of the applicatorcap 210, according to the present disclosure. As illustrated, theapplicator cap 210 has a generally circular cross-section and defines aseries of threads 7302 used to couple the applicator cap 210 to thesensor applicator 102 (FIGS. 29A and 29B). The vents 2908 are alsovisible in the bottom of the applicator cap 210.

The applicator cap 210 may further provide and otherwise define a cappost 3004 centrally located within the interior of the applicator cap210 and extending proximally from the bottom thereof. The cap post 3004may be configured to help support the sensor control device 2602 whilecontained within the sensor applicator 102 (FIGS. 29A-29B). Moreover,the cap post 3004 may define an opening 3006 configured to receive thepreservation vial 2620 as the applicator cap 210 is coupled to thesensor applicator 102.

In some embodiments, the opening 3006 to the cap post 3004 may includeone or more compliant features 3008 that are expandable or flexible toenable the preservation vial 2620 to pass therethrough. In someembodiments, for example, the compliant feature(s) 3008 may comprise acollet-type device that includes a plurality of compliant fingersconfigured to flex radially outward to receive the preservation vial2620. In other embodiments, however, the compliant feature(s) 3008 maycomprise an elastomer or another type of compliant material configuredto expand radially to receive the preservation vial 2620.

FIG. 31 is a cross-sectional side view of the sensor control device 2602positioned within the applicator cap 210, according to one or moreembodiments. As illustrated, the cap post 3004 defines a post chamber3102 configured to receive the preservation vial 2620. The opening 3006to the cap post 3004 provides access into the post chamber 3102 andexhibits a first diameter D₁. In contrast, the enlarged head 2740 of thepreservation vial 2620 exhibits a second diameter D₂ that is larger thanthe first diameter D₁ and greater than the outer diameter of theremaining portions of the preservation vial 2620. Accordingly, as thepreservation vial 2620 is extended into the post chamber 3102, thecompliant feature(s) 3008 of the opening 3006 may flex (expand) radiallyoutward to receive the enlarged head 2740.

In some embodiments, the enlarged head 2740 may provide or otherwisedefine an angled outer surface that helps bias the compliant feature(s)3008 radially outward. The enlarged head 2740, however, may also definean upper shoulder 3104 that prevents the preservation vial 2620 fromreversing out of the post chamber 3102. More specifically, the shoulder3104 may comprise a sharp surface at the second diameter D₂ that willengage but not urge the compliant feature(s) 3008 to flex radiallyoutward in the reverse direction.

Once the enlarged head 2740 bypasses the opening 3006, the compliantfeature(s) 3008 flex back to (or towards) their natural state. In someembodiments, the compliant feature(s) 3008 may engage the outer surfaceof the preservation vial 2620, but may nonetheless allow the applicatorcap 210 to rotate relative to the preservation vial 2620. Accordingly,when a user removes the applicator cap 210 by rotating the applicatorcap 210 relative to the sensor applicator 102 (FIGS. 29A-29B), thepreservation vial 2620 may remain stationary relative to the cap post3004.

Upon removing the applicator cap 210 from the sensor applicator 102, andthereby also separating the sensor control device 2602 from theapplicator cap 210, the shoulder 3104 defined on the enlarged head 2740will engage the compliant feature(s) 3008 at the opening 3006. Becausethe diameter of the shoulder 3104 is greater than the diameter of theopening 3006, the shoulder 3104 will bind against the compliantfeature(s) 3008 and thereby separate the preservation vial 2620 from thesensor control device 2602, which exposes the distal portions of thesensor 2616 and the sharp 2618. Accordingly, the compliant feature(s)3008 may prevent the enlarged head 2740 from exiting the post chamber3102 via the opening 3006 upon separating the applicator cap 210 fromthe sensor applicator 102 and the sensor control device 2602. Theseparated preservation vial 2620 will fall into and remain within thepost chamber 3102.

In some embodiments, instead of the opening 3006 including the compliantfeature(s) 3008, as generally described above, the opening 3006 mayalternatively be threaded. In such embodiments, a small portion near thedistal end of the preservation vial 2620 may also be threaded andconfigured to threadably engage the threads of the opening 3006. Thepreservation vial 2620 may be received within the post chamber 3102 viathreaded rotation. Upon removing the applicator cap 210 from the sensorapplicator 102, however, the opposing threads on the opening 3006 andthe preservation vial 2620 bind and the preservation vial 2620 may beseparated from the sensor control device 2602.

Accordingly, there are several advantages to incorporating the sensorcontrol device 2602 into an analyte monitoring system (e.g., the analytemonitoring system 100 of FIG. 1). Since the sensor control device 2602is finally assembled in a controlled environment, tolerances can bereduced or eliminated altogether, which allows the sensor control device2602 to be thin and small. Moreover, since the sensor control device2602 is finally assembled in a controlled environment, a thoroughpre-test of the sensor control device 2602 can be undertaken at thefactory, thus fully testing the sensor unit prior to packaging for finaldelivery.

Embodiments disclosed herein include:

L. A sensor control device that includes an electronics housing, a plugassembly matable with the electronics housing and including a sensormodule that has a sensor and a sharp module that has a sharp, and apreservation vial coupled to the plug assembly and defining an innerchamber, wherein distal portions of the sensor and the sharp arereceivable within the inner chamber and isolated within the innerchamber from gaseous chemical sterilization.

M. An analyte monitoring system that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing, a plug assembly coupled to theelectronics housing and including a sensor module that has a sensor anda sharp module that has a sharp, and a preservation vial coupled to theplug assembly and defining an inner chamber. The analyte monitoringsystem further including a cap coupled to the sensor applicator toprovide a barrier that seals the sensor control device within the sensorapplicator, wherein distal portions of the sensor and the sharp arereceived within the inner chamber and isolated within the inner chamberfrom gaseous chemical sterilization.

N. A method of preparing an analyte monitoring system including loadinga sensor control device into a sensor applicator, the sensor controldevice including an electronics housing, a plug assembly matable withthe electronics housing and including a sensor module that has a sensorand a sharp module that has a sharp, and a preservation vial coupled tothe plug assembly and defining an inner chamber. The method furtherincluding securing a cap to the sensor applicator and thereby providinga barrier that seals the sensor control device within the sensorapplicator, sterilizing the sensor control device with gaseous chemicalsterilization while the sensor control device is positioned within thesensor applicator, and isolating distal portions of the sensor and thesharp received within the inner chamber from the gaseous chemicalsterilization.

Each of embodiments L, M, and N may have one or more of the followingadditional elements in any combination: Element 1: wherein the sensormodule further includes a plug and the preservation vial is removablycoupled to the plug. Element 2: wherein the preservation vial providesan enlarged head and a diameter of the enlarged head is greater than adiameter of remaining portions of the preservation vial. Element 3:further comprising a seal that provides a sealed barrier between theinner chamber and exterior to the inner chamber, wherein the distalportions of the sensor and the sharp penetrate the seal and extend intothe inner chamber. Element 4: further comprising a preservation fluidwithin the inner chamber that isolates the distal portions of the sensorand the sharp from the gaseous chemical sterilization. Element 5:wherein the distal portions of the sensor and the sharp are at leastpartially immersed in the preservation fluid. Element 6: wherein thepreservation fluid comprises an inert and biocompatible fluid selectedfrom the group consisting of silicone oil, mineral oil, a gel, a wax,fresh water, salt water, a synthetic fluid, glycerol, sorbitan esters,and any combination thereof. Element 7: wherein the preservation fluidincludes an anti-inflammatory agent.

Element 8: wherein the cap provides a cap post that defines a postchamber and an opening that receives an enlarged head of thepreservation vial into the post chamber. Element 9: wherein the openingincludes one or more compliant features that flex radially outward toreceive the enlarged head. Element 10: wherein the one or more compliantfeatures comprise a plurality of compliant fingers. Element 11: whereinthe one or more compliant features prevent the enlarged head fromexiting the post chamber through the opening upon separating the capfrom the sensor applicator and the sensor control device. Element 12:wherein the cap is rotatable relative to the preservation vial when thepreservation vial is received within the post chamber. Element 13:further comprising a preservation fluid within the inner chamber thatisolates the distal portions of the sensor and the sharp from thegaseous chemical sterilization.

Element 14: wherein loading the sensor control device into a sensorapplicator is preceded by assembling the plug assembly, coupling thepreservation vial to the plug assembly such that the distal portions ofthe sensor and the sharp are received within the inner chamber, andcoupling the plug assembly to an electronics housing and therebyproviding the sensor control device. Element 15: wherein coupling thepreservation vial to the plug assembly is preceded by sterilizing theplug assembly with radiation sterilization. Element 16: whereinisolating the distal portions of the sensor and the sharp from thegaseous chemical sterilization comprises at least partially immersingthe distal portions of the sensor and the sharp within a preservationfluid present within the inner chamber. Element 17: wherein the capprovides a cap post that defines a post chamber having one or morecompliant features arranged at an opening to the post chamber, andwherein securing the cap to the sensor applicator comprises receiving anenlarged head of the preservation vial into the post chamber via theopening, and flexing the one or more compliant features radially outwardto receive the enlarged head.

By way of non-limiting example, exemplary combinations applicable to L,M, and N include: Element 4 with Element 5; Element 4 with Element 6;Element 4 with Element 7; Element 8 with Element 9; Element 9 withElement 10; Element 9 with Element 17; Element 8 with Element 12;Element 8 with Element 13; and Element 14 with Element 15.

Isolating One-Piece Sensor Design with Focused E-beam Sterilization

FIGS. 32A and 32B are isometric and side views, respectively, of anexample sensor control device 3202, according to one or more embodimentsof the present disclosure. The sensor control device 3202 (alternatelyreferred to as a “puck”) may be similar in some respects to the sensorcontrol device 104 of FIG. 1 and therefore may be best understood withreference thereto. In some applications, the sensor control device 3202may replace the sensor control device 104 of FIG. 1 and, therefore, maybe used in conjunction with the sensor applicator 102 (FIG. 1), whichdelivers the sensor control device 3202 to a target monitoring locationon a user's skin.

The sensor control device 3202, however, may be incorporated into aone-piece system architecture in contrast to the sensor control device104 of FIG. 1. Unlike the two-piece architecture, for example, a user isnot required to open multiple packages and finally assemble the sensorcontrol device 3202 before use. Rather, upon receipt by the user, thesensor control device 3202 is already fully assembled and properlypositioned within the sensor applicator 102 (FIG. 1). To use the sensorcontrol device 3202, the user need only open one barrier (e.g., removingthe applicator cap 210 of FIG. 2B) before promptly delivering the sensorcontrol device 3202 to the target monitoring location.

As illustrated, the sensor control device 3202 includes an electronicshousing 3204 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing3204 may exhibit other cross-sectional shapes, such as ovoid orpolygonal, without departing from the scope of the disclosure. Theelectronics housing 3204 may be configured to house or otherwise containvarious electrical components used to operate the sensor control device3202.

The electronics housing 3204 may include a shell 3206 and a mount 3208that is matable with the shell 3206. The shell 3206 may be secured tothe mount 3208 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic (or ultrasonic) welding, using one or moremechanical fasteners (e.g., screws), or any combination thereof. In someembodiments, the interface between the shell 3206 and the mount 3208 maybe sealed. In such embodiments, a gasket or other type of seal materialmay be positioned or applied at or near the outer diameter (periphery)of the shell 3206 and the mount 3208. Securing the shell 3206 to themount 3208 may compress the seal material and thereby generate a sealedinterface. In at least one embodiment, an adhesive may be applied to theouter diameter (periphery) of one or both of the shell 3206 and themount 3208, and the adhesive may not only secure the shell 3206 to themount 3208 but may also seal the interface.

In embodiments where a sealed interface is created between the shell3206 and the mount 3208, the interior of the electronics housing 3204may be effectively isolated from outside contamination between the twocomponents. In such embodiments, if the sensor control device 3202 isassembled in a controlled and sterile environment, there may be no needto sterilize the internal electrical components (e.g., via gaseouschemical sterilization). Rather, the sealed engagement may provide asufficient sterile barrier for the assembled electronics housing 3204.

The sensor control device 3202 may further include a sensor module 3210(partially visible in FIG. 32B) and a sharp module 3212 (partiallyvisible). The sensor and sharp modules 3210, 3212 may beinterconnectable and coupled to the electronics housing 3204. The sensormodule 3210 may be configured to carry and otherwise include a sensor3214 (FIG. 32B), and the sharp module 3212 may be configured to carryand otherwise include a sharp 3216 (FIG. 32B) used to help deliver thesensor 3214 transcutaneously under a user's skin during application ofthe sensor control device 3202.

As illustrated in FIG. 32B, corresponding portions of the sensor 3214and the sharp 3216 extend from the electronics housing 3204 and, moreparticularly, from the bottom of the mount 3208. The exposed portion ofthe sensor 3214 may be received within a hollow or recessed portion ofthe sharp 3216. The remaining portion(s) of the sensor 3214 is/arepositioned within the interior of the electronics housing 3204.

An adhesive patch 3218 may be positioned on and otherwise attached tothe underside of the mount 3208. Similar to the adhesive patch 108 ofFIG. 1, the adhesive patch 3218 may be configured to secure and maintainthe sensor control device 3202 in position on the user's skin duringoperation. In some embodiments, a transfer adhesive 3220 may interposethe adhesive patch 3218 and the bottom of the mount 3208. The transferadhesive 3220 may help facilitate the assembly process of the sensorcontrol device 3202.

FIGS. 33A and 33B are exploded perspective top and bottom views,respectively, of the sensor control device 3202, according to one ormore embodiments. As illustrated, the shell 3206 and the mount 3208 ofthe electronics housing 3204 operate as opposing clamshell halves thatenclose or otherwise substantially encapsulate the various electroniccomponents of the sensor control device 3202.

A printed circuit board (PCB) 3302 may be positioned within theelectronics housing 3204. As shown in FIG. 33B, a plurality ofelectronic modules 3304 may be mounted to the underside of the PCB 3302.Example electronic modules 3304 include, but are not limited to,resistors, transistors, capacitors, inductors, diodes, and switches. Adata processing unit 3306 (FIG. 33B) may also be mounted to the PCB 3302and may comprise, for example, an application specific integratedcircuit (ASIC) configured to implement one or more functions or routinesassociated with operation of the sensor control device 3202. Morespecifically, the data processing unit 3306 may be configured to performdata processing functions, such as filtering and encoding of datasignals, each of which corresponds to a sampled analyte level of theuser. The data processing unit 3306 may also include or otherwisecommunicate with an antenna for communicating with the reader device 106(FIG. 1).

As illustrated, the shell 3206, the mount 3208, and the PCB 3302 eachdefine corresponding central apertures 3308 a, 3308 b, 3308 c,respectively. When the sensor control device 3202 is assembled, thecentral apertures 3308 a-c coaxially align to receive portions of thesensor and sharp modules 3210, 3212 therethrough.

A battery 3310 and a corresponding battery mount 3312 may also be housedwithin the electronics housing 3204. The battery 3310 may be configuredto power the sensor control device 3202.

The sensor module 3210 may include the sensor 3214 and a connector 3314.The sensor 3214 includes a tail 3316, a flag 3318, and a neck 3320 thatinterconnects the tail 3316 and the flag 3318. The tail 3316 may beconfigured to extend through the central aperture 3308 b defined in themount 3208 and extend distally from the underside thereof. The tail 3316includes an enzyme or other chemistry or biologic and, in someembodiments, a membrane may cover the chemistry. In use, the tail 3316is transcutaneously received beneath a user's skin, and the chemistryincluded thereon helps facilitate analyte monitoring in the presence ofbodily fluids.

The flag 3318 may comprise a generally planar surface having one or moresensor contacts 3322 (three shown in FIG. 33A) disposed thereon. Theflag 3318 may be configured to be received within the connector 3314where the sensor contact(s) 3322 align with a corresponding number ofcompliant carbon impregnated polymer modules (not shown) encapsulatedwithin the connector 3314.

The connector 3314 includes one or more hinges 3324 that enables theconnector 3314 to pivot between open and closed states. The connector3314 is depicted in FIGS. 33A-33B in the closed state, but cantransition to the open state to receive the flag 3318 and the compliantcarbon impregnated polymer module(s) therein. The compliant carbonimpregnated polymer module(s) provide electrical contacts 3326 (threeshown in FIG. 33A) configured to provide conductive communicationbetween the sensor 3214 and corresponding circuitry contacts 3328provided on the PCB 3302. When the sensor module 3210 is properlycoupled to the electronics housing 3204, the circuitry contacts 3328make conductive communication with the electrical contacts 3326 of theconnector 3314. The connector 3314 can be made of silicone rubber andmay serve as a moisture barrier for the sensor 3214.

The sharp module 3212 includes the sharp 3216 and a sharp hub 3330 thatcarries the sharp 3216. The sharp 3216 includes an elongate shaft 3332and a sharp tip 3334 at the distal end of the shaft 3332. The shaft 3332may be configured to extend through each of the coaxially alignedcentral apertures 3308 a-c and extend distally from the bottom of themount 3208. Moreover, the shaft 3332 may include a hollow or recessedportion 3336 that at least partially circumscribes the tail 3316 of thesensor 3214. The sharp tip 3334 may be configured to penetrate the skinwhile carrying the tail 3316 to put the active chemistry of the tail3316 into contact with bodily fluids.

The sharp hub 3330 may include a hub small cylinder 3338 and a hub snappawl 3340, each of which may be configured to help couple the sensorcontrol device 3202 to the sensor applicator 102 (FIG. 1).

Referring specifically to FIG. 33A, in some embodiments the sensormodule 3210 may be at least partially received within a sensor mountpocket 3342 included within the electronics housing 3204. In someembodiments, the sensor mount pocket 3342 may comprise a separatestructure, but may alternatively form an integral part or extension ofthe mount 3208. The sensor mount pocket 3342 may be shaped and otherwiseconfigured to receive and seat the sensor 3214 and the connector 3314.As illustrated, the sensor mount pocket 3342 defines an outer periphery3344 that generally circumscribes the region where the sensor 3214 andthe connector 3314 are to be received. In at least one embodiment, theouter periphery 3344 may be sealed to the underside of the PCB 3302 whenthe electronics housing 3204 is fully assembled. In such embodiments, agasket (e.g., an O-ring or the like), an adhesive, or another type ofseal material may be applied (arranged) at the outer periphery 3344 andmay operate to seal the interface between the sensor mount pocket 3342and the PCB 3302.

Sealing the interface between the sensor mount pocket 3342 and theunderside of the PCB 3302 may help create or define a sealed zone orregion within the electronics housing 3204. The sealed region may proveadvantageous in helping to isolate (protect) the tail 3316 of the sensor3214 from potentially harmful sterilization gases used during gaseouschemical sterilization.

Referring specifically to FIG. 33B, a plurality of channels or grooves3346 may be provided or otherwise defined on the bottom of the mount3208. As illustrated, the grooves 3346 may form a plurality ofconcentric rings in combination with a plurality of radially extendingchannels. The adhesive patch 3218 (FIGS. 32A-32B) may be attached to theunderside of the mount 3208, and, in some embodiments, the transferadhesive 3220 (FIGS. 32A-32B) may interpose the adhesive patch 3218 andthe bottom of the mount 3208. The grooves 3346 may prove advantageous inpromoting the egress of moisture away from the center of the electronicshousing 3204 beneath the adhesive patch 3218.

In some embodiments, a cap post seal interface 3348 may be defined onthe bottom of the mount 3208 at the center of the mount 3208. Asillustrated, the cap post seal interface 3348 may comprise asubstantially flat portion of the bottom of the mount 3208. The secondcentral aperture 3308 b is defined at the center of the cap post sealinterface 3348 and the grooves 3346 may circumscribe the cap post sealinterface 3348. The cap post seal interface 3348 may provide a sealingsurface that may help isolate (protect) the tail 3316 of the sensor 3214from potentially harmful sterilization gases used during gaseouschemical sterilization.

FIGS. 34A and 34B are side and cross-sectional side views, respectively,of the sensor applicator 102 with the applicator cap 210 coupledthereto. More specifically, FIGS. 34A-34B depict how the sensorapplicator 102 might be shipped to and received by a user. According tothe present disclosure, and as seen in FIG. 34B, the sensor controldevice 3202 is already assembled and installed within the sensorapplicator 102 prior to being delivered to the user. The applicator cap210 may be threaded to the housing 208 and include a tamper ring 3402.Upon rotating (e.g., unscrewing) the applicator cap 210 relative to thehousing 208, the tamper ring 3402 may shear and thereby free theapplicator cap 210 from the sensor applicator 102. Following which, theuser may deliver the sensor control device 3202 to the target monitoringlocation, as generally described above with reference to FIGS. 2E-2G.

With specific reference to FIG. 34B, the sensor control device 3202 maybe loaded into the sensor applicator 102 by mating the sharp hub 3330with a sensor carrier 3404 included within the sensor applicator 102.More specifically, the hub small cylinder 3338 and the hub snap pawl3340 may be received by corresponding mating features of the sensorcarrier 3404.

Once the sensor control device 3202 is mated with the sensor carrier3404, the applicator cap 210 may then be secured to the sensorapplicator 102. As illustrated, the applicator cap 210 may provide andotherwise define a cap post 3406 centrally located within the interiorof the applicator cap 210 and extending proximally from the bottomthereof. The cap post 3406 may be configured to help support the sensorcontrol device 3202 while contained within the sensor applicator 102.Moreover, the cap post 3406 may define a post chamber 3408 configured toreceive the sensor 3214 and the sharp 3216 as extending from the bottomof the electronics housing 3204. When the sensor control device 3202 isloaded into the sensor applicator 102, the sensor 3214 and the sharp3216 may be arranged within a sealed region 3410 at least partiallydefined by the post chamber 3408 and configured to isolate the sensor3214 and the sharp 3216 during gaseous chemical sterilization.

In some embodiments, prior to assembling and loading the sensor controldevice 3202 into the sensor applicator 102, the sensor and sharp modules3210, 3212 may be subjected to radiation sterilization to sterilize thedistal portions of the sensor 3214 and the sharp 3216. Once properlysterilized, the sensor and sharp modules 3210, 3212 may then be coupledto the electronics housing 3204 and the fully assembled sensor controldevice 3202 may then be loaded into the sensor applicator 102 asdescribed above.

In other embodiments, however, the fully assembled sensor control device3202 may first be loaded into the sensor applicator 102 and the sensorand sharp modules 3210, 3212 may then be subjected to radiationsterilization 3412 while positioned within the sensor applicator 102.The radiation sterilization 3412 may comprise, for example, e-beamirradiation, but other methods of sterilization may alternatively beused including, but not limited to, gamma ray irradiation, X-rayirradiation, or any combination thereof.

In some embodiments, as illustrated, the sensor control device 3202 maybe subjected to “focused” radiation sterilization 3412, where theradiation (e.g., beams, waves, etc.) from the radiation sterilization3412 is applied and otherwise directed only toward the sensor and sharpmodules 3210, 3212 (e.g., the sensor 3214 and the sharp 3216). In suchembodiments, the electrical components 3304 (FIG. 33B) coupled to thePCB 3302 (FIGS. 33A-33B), including the data processing unit 3306 (FIG.33B), may be positioned out of the range of the propagating radiationand, therefore, will not be affected by the radiation. The electricalcomponents 3304 and the data processing unit 3306, for example, may bepositioned on the PCB 3302 near its outer periphery so as not to fallwithin the range (span) of the focused radiation sterilization 3412. Inother embodiments, this may be accomplished by shielding the sensitiveelectrical components 3304 with proper electromagnetic shields.

According to the present disclosure, while loaded in the sensorapplicator 102, the sensor control device 3202 may be subjected togaseous chemical sterilization 3414 to sterilize the electronics housing3204 and any other exposed portions of the sensor control device 3202.To accomplish this, a chemical may be injected into a sterilizationchamber 3416 cooperatively defined by the sensor applicator 102 and theinterconnected cap 210. In some applications, the chemical may beinjected via one or more vents 3418 defined in the applicator cap 210 atits proximal end 3420. Example chemicals that may be used for thegaseous chemical sterilization 3414 include, but are not limited to,ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxide (e.g.,nitrous oxide, nitrogen dioxide, etc.).

Since the sensor 3214 and the sharp 3216 are sealed within the sealedregion 3410, the chemicals used during the gaseous chemicalsterilization process do not interact with the enzymes, chemistry orbiologics provided on the tail 3316.

Once a desired sterility assurance level has been achieved within thesterilization chamber 3416, the gaseous solution is removed and thesterilization chamber 3416 is aerated. Aeration may be achieved by aseries of vacuums and subsequently circulating nitrogen gas or filteredair through the sterilization chamber 3416. Once the sterilizationchamber 3416 is properly aerated, the vents 3418 may be occluded with aseal 3422 (shown in dashed lines) applied to the proximal end 3420 ofthe applicator cap 210.

In some embodiments, the seal 3422 may comprise two or more layers ofdifferent materials. The first layer may be made of a synthetic material(e.g., a flash-spun high-density polyethylene fiber), such as Tyvek®available from DuPont®. Tyvek® is highly durable and puncture resistantand allows the permeation of vapors. The Tyvek® layer can be appliedbefore the gaseous chemical sterilization 3414, and following thegaseous chemical sterilization 3414, a foil or other vapor and moistureresistant material layer may be sealed (e.g., heat sealed) over theTyvek® layer to prevent the ingress of contaminants and moisture intothe sterilization chamber 3416. In other embodiments, the seal 3422 maycomprise only a single protective layer applied to the applicator cap210. In such embodiments, the single layer is gas permeable for thesterilization process, but is also capable of protection againstmoisture and other harmful elements once the sterilization process iscomplete.

With the seal 3422 in place, the applicator cap 210 provides a barrieragainst outside contamination, and thereby maintains a sterileenvironment for the assembled sensor control device 3202 until the userremoves (unthreads) the applicator cap 210. The applicator cap 210 mayalso create a dust-free environment during shipping and storage thatprevents the adhesive patch 3218 used to secure the sensor controldevice 3202 to the user's skin from becoming dirty.

FIG. 35 is an enlarged cross-sectional side view of the sensor controldevice 3202 mounted within the sensor applicator 102 with the applicatorcap 210 secured thereto, according to one or more embodiments. Asindicated above, portions of the sensor 3214 and the sharp 3216 may bearranged within the sealed region 3410 and thereby protected fromsubstances that might adversely interact with the chemistry of thesensor 3214. More specifically, the gases used during the gaseouschemical sterilization 3414 (FIG. 34B) can adversely affect the enzymesprovided on the tail 3316 of the sensor 3214, and the sealed region 3410protects the tail 3316 from the ingress of such chemicals.

As illustrated, the sealed region 3410 may include (encompass) selectportions of the interior of the electronics housing 3204 and the postchamber 3408 of the cap post 3406. In one or more embodiments, thesealed region 3410 may be defined and otherwise formed by at least afirst seal 3502 a, a second seal 3502 b, and a third seal 3502 c. Thefirst seal 3502 a may be arranged to seal the interface between thesharp hub 3330 and the shell 3206. Moreover, the first seal 3502 a maycircumscribe the first central aperture 3308 a defined in the shell 3206such that fluids (e.g., gaseous chemicals) are prevented from migratinginto the interior of the electronics housing 3204 via the first centralaperture 3308 a.

In some embodiments, the first seal 3502 a may form part of the sharphub 3330. For example, the first seal 3502 a may be overmolded onto thesharp hub 3330. In other embodiments, the first seal 3502 a may beovermolded onto the top surface of the shell 3206. In yet otherembodiments, the first seal 3502 a may comprise a separate structure,such as an O-ring or the like, that interposes the sharp hub 3330 andthe top surface of the shell 3206, without departing from the scope ofthe disclosure.

The second seal 3502 b may be arranged to seal the interface between thecap post 3406 and the bottom of the mount 3208, and the second seal 3502b may circumscribe the second central aperture 3308 b defined in themount 3208. Consequently, the second seal 3502 b may prevent fluids(e.g., gaseous chemicals) from migrating into the post chamber 3408 ofthe cap post 3406 and also from migrating into the interior of theelectronics housing 3204 via the second central aperture 3308 b.

In some embodiments, the second seal 3502 b may form part of the cappost 3406. For example, the second seal 3502 b may be overmolded ontothe top of the cap post 3406. In other embodiments, the second seal 3502b may be overmolded onto the cap post seal interface 3348 at the bottomof the mount 3208. In yet other embodiments, the second seal 3502 b maycomprise a separate structure, such as an O-ring or the like, thatinterposes the cap post 3406 and the bottom of the mount 3208, withoutdeparting from the scope of the disclosure.

Upon loading the sensor control device 3202 into the sensor applicator102 and securing the applicator cap 210 to the sensor applicator 102,the first and second seals 3502 a,b become compressed and generatecorresponding sealed interfaces. The first and second seals 3502 a,b maybe made of a variety of materials capable of generating a sealedinterface between opposing structures. Suitable materials include, butare not limited to, silicone, a thermoplastic elastomer (TPE),polytetrafluoroethylene (Teflon®), rubber, an elastomer, or anycombination thereof.

The third seal 3502 c may be arranged to seal an interface between thesensor mount pocket 3342 and the PCB 3302 and, more particularly,between the outer periphery 3344 of the sensor mount pocket 3342 and theunderside of the PCB 3302. The third seal 3502 c may comprise a gasket(e.g., an O-ring or the like), an adhesive, or another type of sealmaterial applied (arranged) at the outer periphery 3344. In operation,the third seal 3502 c may prevent fluids (e.g., gaseous chemicals,liquids, etc.) from migrating into the interior of the sensor mountpocket 3342 and, therefore, into the post chamber 3408 to adverselyreact with the enzymes on the tail 3316.

The applicator cap 210 may be secured to the sensor applicator 102 bythreading the applicator cap 210 to the sensor applicator 102 viarelative rotation. As the applicator cap 210 rotates relative to thesensor applicator 102, the cap post 3406 advances until the second seal3502 b engages the cap post seal interface 3348 at the bottom of themount 3208. Upon engaging the cap post seal interface 3348, the secondseal 3502 b may frictionally engage the mount 3208 and thereby urgecorresponding rotation of the entire electronics housing 3204 in thesame angular direction.

In prior art sensor control devices, such as the sensor control device104 of FIG. 1, conical carrier grip features are commonly defined on theexterior of the electronics housing and configured to mate withcorresponding conical features provided on radially biased arms of thesensor mount pocket 3342. Mating engagement between these correspondingconical features helps prevent the electronics housing from rotatingwithin the sensor applicator 102.

In contrast, the electronics housing 3204 of the presently disclosedsensor control device 3202 provides or otherwise defines an angled andotherwise continuously smooth exterior surface 3504 about its outerdiameter (periphery). In some embodiments, as illustrated, the smoothexterior surface 3504 may be provided on the mount 3208, but mayalternatively be provided on the shell 3206, without departing from thescope of the disclosure. One or more radially biased arms of the sensormount pocket 3342 may be positioned to engage the exterior surface 3504to help center the sensor control device 3202 within the sensorapplicator 102. As the electronics housing 3204 is urged to rotatethrough frictional engagement between the second seal 3502 b and thebottom of the mount 3208, the exterior surface 3504 slidingly engagesthe radially biased arms, which do not inhibit rotation thereof.

FIG. 36 is an enlarged cross-sectional bottom view of the sensor controldevice 3202 positioned atop the cap post 3406, according to one or moreembodiments. As illustrated, the adhesive patch 3218 is positioned onthe underside of the mount 3208 and the transfer adhesive 3220interposes the adhesive patch 3218 and the mount 3208.

The adhesive patch 3218 may occlude or otherwise cover most of thegrooves 3346 defined on the bottom of the mount 3208. Moreover, asillustrated, the adhesive patch 3218 may extend a short distance intothe cap post seal interface 3348. To enable the grooves 3346 to properlydirect moisture away from the center of the electronics housing 3204 andfrom the cap post seal interface 3348, the adhesive patch 3218 (and thetransfer adhesive 3220, if included) may provide or otherwise define oneor more channels 3602 aligned with and otherwise arranged to fluidlycommunicate with the grooves 3346. In the illustrated embodiment, thechannels 3602 extend radially outward from the center of the electronicshousing 3204, but may alternatively be defined in other configurationsand nonetheless interconnect with the grooves 3346 to facilitate fluidcommunication therebetween.

In operation, as moisture builds up around the center of the electronicshousing 3204 and at the cap post seal interface 3348, the moisture isable to flow into the grooves 3346 via the channels 3602. Once in thegrooves 3346, the moisture is able to flow radially outward beneath theadhesive patch 3218 and toward the outer periphery of the sensor controldevice 3202.

Embodiments disclosed herein include:

O. An analyte monitoring system that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing having a shell and a mount matable withthe shell, a printed circuit board positioned within the electronicshousing, a sensor extending from a bottom of the mount, a sharp hubpositioned adjacent a top of the shell, and a sharp carried by the sharphub and extending through the electronics housing and from the bottom ofthe mount. The analyte monitoring system further including a cap coupledto the sensor applicator and providing a cap post that defines a postchamber that receives the sensor and the sharp extending from the bottomof the mount, and a sealed region encompassing the post chamber and aportion of an interior of the electronics housing, wherein the sealedregion is defined by a first seal that seals an interface between thesharp hub and the shell, a second seal that seals an interface betweenthe cap post and the bottom of the mount, and a third seal that seals aninterface between the mount and the printed circuit board, and whereinportions of the sensor and the sharp reside within the sealed region andare thereby isolated from gaseous chemical sterilization.

P. A method of preparing an analyte monitoring system including loadinga sensor control device into a sensor applicator, the sensor controldevice including an electronics housing having a shell and a mountmatable with the shell, a printed circuit board positioned within theelectronics housing, a sensor module having a sensor extending from abottom of the mount, and a sharp module having a sharp hub and a sharpcarried by the sharp hub, wherein the sharp extends through theelectronics housing and from the bottom of the mount. The method furtherincluding securing a cap to the sensor applicator, wherein the capprovides a cap post that defines a post chamber that receives the sensorand the sharp extending from the bottom of the mount, creating a sealedregion as the cap is secured to the sensor applicator, the sealed regionencompassing the post chamber and a portion of an interior of theelectronics housing, wherein portions of the sensor and the sharp residewithin the sealed region, sterilizing the sensor control device withgaseous chemical sterilization while the sensor control device ispositioned within the sensor applicator, and isolating the portions ofthe sensor and the sharp residing within the sealed region from thegaseous chemical sterilization.

Each of embodiments O and P may have one or more of the followingadditional elements in any combination: Element 1: wherein the firstseal circumscribes a central aperture defined in the shell and preventsfluids from migrating into the portion of the interior of theelectronics housing via the central aperture. Element 2: wherein thesecond seal circumscribes a central aperture defined in the mount andprevents fluids from migrating into the portion of the interior of theelectronics housing via the central aperture and further prevents thefluids from migrating into the post chamber. Element 3: wherein thefirst seal is overmolded onto the sharp hub. Element 4: wherein thefirst seal interposes the sharp hub and a top surface of the shell.Element 5: wherein the second seal is overmolded onto the cap post.Element 6: wherein the second seal interposes the cap post and a bottomsurface of the mount. Element 7: wherein the first and second seals aremade of a material selected from the group consisting of silicone, athermoplastic elastomer, polytetrafluoroethylene, and any combinationthereof. Element 8: wherein the mount provides a sensor mount pocketthat at least partially receives a sensor module within the electronicshousing, and wherein the third seal is positioned at an outer peripheryof the sensor mount pocket. Element 9: wherein the third seal comprisesone of a gasket and an adhesive. Element 10: further comprising aplurality of grooves defined on the bottom of the mount, and a cap postseal interface defined on the bottom of the mount at a center of themount, wherein the second seal seals against the cap post sealinterface. Element 11: further comprising an adhesive patch coupled tothe bottom of the mount and extending radially into the cap post sealinterface, and one or more channels defined in the adhesive patch andinterconnecting with the plurality of grooves to facilitate fluidcommunication between the cap post seal interface and the plurality ofgrooves. Element 12: wherein the electronics housing defines an angledand smooth exterior surface that allows the sensor control device torotate unobstructed relative to the sensor applicator as the cap iscoupled to the sensor applicator.

Element 13: wherein creating the sealed region as the cap is secured tothe sensor applicator comprises sealing an interface between the sharphub and the shell with a first seal, sealing an interface between thecap post and the bottom of the mount with a second seal, and sealing aninterface between the mount and the printed circuit board with a thirdseal. Element 14: wherein loading the sensor control device into asensor applicator is preceded by sterilizing the sensor and the sharpwith radiation sterilization, and assembling the sensor and sharpmodules to the electronics housing. Element 15: wherein sterilizing thesensor control device with the gaseous chemical sterilization ispreceded by sterilizing the sensor and the sharp with radiationsterilization while the sensor control device is positioned within thesensor applicator. Element 16: wherein the radiation sterilization is atleast one of focused radiation sterilization and low-energy radiationsterilization. Element 17: wherein the electronics housing defines anangled and smooth exterior surface, the method further comprisingallowing the sensor control device to rotate relative to the sensorapplicator as the cap is secured to the sensor applicator.

By way of non-limiting example, exemplary combinations applicable to Oand P include: Element 1 with Element 2; Element 1 with Element 3;Element 1 with Element 4; Element 1 with Element 5; Element 1 withElement 6; Element 1 with Element 7; Element 1 with Element 8; Element 3with Element 4; Element 3 with Element 5; Element 3 with Element 6;Element 10 with Element 11; and Element 15 with Element 16.

One-Piece Puck Architecture with ASIC Shields, Use of Low and MediumEnergy Radiation Sterilization, and Magnetic Deflection

FIGS. 37A-37C are isometric, side, and bottom views, respectively, of anexample sensor control device 3702, according to one or more embodimentsof the present disclosure. The sensor control device 3702 (alternatelyreferred to as an on-body patch or unit) may be similar in some respectsto the sensor control device 104 of FIG. 1 and therefore may be bestunderstood with reference thereto. The sensor control device 3702 mayreplace the sensor control device 104 of FIG. 1 and, therefore, may beused in conjunction with the sensor applicator 102 (FIG. 1), whichdelivers the sensor control device 3702 to a target monitoring locationon a user's skin. However, in contrast to the sensor control device 104of FIG. 1, various structural advantages and improvements allow thesensor control device 3702 to be incorporated into a one-piece systemarchitecture.

Unlike the sensor control device 104 of FIG. 1, for example, a user isnot required to open multiple packages and finally assemble the sensorcontrol device 3702 prior to delivery to the target monitoring location.Rather, upon receipt by the user, the sensor control device 3702 mayalready be assembled and properly positioned within the sensorapplicator 102. To use the sensor control device 3702, the user needonly break one barrier (e.g., the applicator cap 210 of FIG. 2B) beforepromptly delivering the sensor control device 3702 to the targetmonitoring location.

Referring first to FIG. 37A, the sensor control device 3702 comprises anelectronics housing 3704 that is generally disc-shaped and may have agenerally circular cross-section. In other embodiments, however, theelectronics housing 3704 may exhibit other cross-sectional shapes, suchas ovoid or polygonal, without departing from the scope of thedisclosure. The electronics housing 3704 may include a shell 3706 and amount 3708 that is matable with the shell 3706. An adhesive patch 3710may be positioned on and otherwise attached to the underside of themount 3708. Similar to the adhesive patch 108 of FIG. 1, the adhesivepatch 3710 may be configured to secure and maintain the sensor controldevice 3702 in position on the user's skin during operation.

In some embodiments, the shell 3706 may define a reference feature 3712.As illustrated, the reference feature 3712 may comprise a depression orblind pocket defined in the shell 3706 and extending a short distanceinto the interior of the electronics housing 3704. The reference feature3712 may operate as a “datum c” feature configured to help facilitatecontrol of the sensor control device 3702 in at least one degree offreedom during factory assembly. In contrast, prior sensor controldevices (e.g., the sensor control device 104 of FIG. 1) typicallyinclude a tab extending radially from the side of the shell. The tab isused as an in-process clocking datum, but must be removed at the end offabrication, and followed by an inspection of the shell where the tabonce existed, which adds complexity to the prior fabrication process.

The shell 3706 may also define a central aperture 3714 sized to receivea sharp (not shown) that is extendable through the center of theelectronics housing 3704.

FIG. 37B depicts a portion of a sensor 3716 extending from theelectronics housing 3704. The remaining portion(s) of the sensor 3716is/are positioned within the interior of the electronics housing 3704.Similar to the sensor 110 of FIG. 1, the exposed portion of the sensor3716 is configured to be transcutaneously positioned under the user'sskin during use. The exposed portion of the sensor 3716 can include anenzyme or other chemistry or biologic and, in some embodiments, amembrane may cover the chemistry.

The sensor control device 3702 provides structural improvements thatresult in a height H and a diameter D that may be less than prior sensorcontrol devices (e.g., the sensor control device 104 of FIG. 1). In atleast one embodiment, for example, the height H may be about 1 mm ormore less than the height of prior sensor control devices, and thediameter D may be about 2 mm or more less than the diameter of priorsensor control devices.

Moreover, the structural improvements of the sensor control device 3702allows the shell 3706 to provide or otherwise define a chamfered orangled outer periphery 3718. In contrast, prior sensor control devicescommonly require a rounded or outwardly arcuate outer periphery toaccommodate internal components. The reduced height H, the reduceddiameter D, and the angled outer periphery 3718 may each proveadvantageous in providing a sensor control device 3702 that is thinner,smaller, and less prone to being prematurely detached by catching onsharp corners or the like while attached to the user's skin.

FIG. 37C depicts a central aperture 3720 defined in the underside of themount 3708. The central aperture 3720 may be sized to receive acombination sharp (not shown) and sensor 3716, where the sensor 3716 isreceived within a hollow or recessed portion of the sharp. When theelectronics housing 3704 is assembled, the central aperture 3720coaxially aligns with the central aperture 3714 (FIG. 37A) of the shell3706 (FIG. 37A) and the sharp penetrates the electronics housing byextending simultaneously through each central aperture 3714, 3720.

FIGS. 38A and 38B are exploded top and bottom views, respectively, ofthe sensor control device 3702, according to one or more embodiments.The shell 3706 and the mount 3708 operate as opposing clamshell halvesthat enclose or otherwise substantially encapsulate the variouselectronic components of the sensor control device 3702. As illustrated,the sensor control device 3702 may include a printed circuit boardassembly (PCBA) 3802 that includes a printed circuit board (PCB) 3804having a plurality of electronic modules 3806 coupled thereto. Exampleelectronic modules 3806 include, but are not limited to, resistors,transistors, capacitors, inductors, diodes, and switches. Prior sensorcontrol devices commonly stack PCB components on only one side of thePCB. In contrast, the PCB components 3806 in the sensor control device3702 can be dispersed about the surface area of both sides (i.e., topand bottom surfaces) of the PCB 3804.

Besides the electronic modules 3806, the PCBA 3802 may also include adata processing unit 3808 mounted to the PCB 3804. The data processingunit 3808 may comprise, for example, an application specific integratedcircuit (ASIC) configured to implement one or more functions or routinesassociated with operation of the sensor control device 3702. Morespecifically, the data processing unit 3808 may be configured to performdata processing functions, where such functions may include but are notlimited to, filtering and encoding of data signals, each of whichcorresponds to a sampled analyte level of the user. The data processingunit 3808 may also include or otherwise communicate with an antenna forcommunicating with the reader device 106 (FIG. 1).

A battery aperture 3810 may be defined in the PCB 3804 and sized toreceive and seat a battery 3812 configured to power the sensor controldevice 3702. An axial battery contact 3814 a and a radial batterycontact 3814 b may be coupled to the PCB 3804 and extend into thebattery aperture 3810 to facilitate transmission of electrical powerfrom the battery 3812 to the PCB 3804. As their names suggest, the axialbattery contact 3814 a may be configured to provide an axial contact forthe battery 3812, while the radial battery contact 3814 b may provide aradial contact for the battery 3812. Locating the battery 3812 withinthe battery aperture 3810 with the battery contacts 3814 a,b helpsreduce the height H (FIG. 37B) of the sensor control device 3702, whichallows the PCB 3804 to be located centrally and its components to bedispersed on both sides (i.e., top and bottom surfaces). This also helpsfacilitate the chamfer 3718 (FIG. 37B) provided on the electronicshousing 3704.

The sensor 3716 may be centrally located relative to the PCB 3804 andinclude a tail 3816, a flag 3818, and a neck 3820 that interconnects thetail 3816 and the flag 3818. The tail 3816 may be configured to extendthrough the central aperture 3720 of the mount 3708 to betranscutaneously received beneath a user's skin. Moreover, the tail 3816may have an enzyme or other chemistry included thereon to helpfacilitate analyte monitoring.

The flag 3818 may include a generally planar surface having one or moresensor contacts 3822 (three shown in FIG. 38B) arranged thereon. Thesensor contact(s) 3822 may be configured to align with and engage acorresponding one or more circuitry contacts 3824 (three shown in FIG.38A) provided on the PCB 3804. In some embodiments, the sensorcontact(s) 3822 may comprise a carbon impregnated polymer printed orotherwise digitally applied to the flag 3818. Prior sensor controldevices typically include a connector made of silicone rubber thatencapsulates one or more compliant carbon impregnated polymer modulesthat serve as electrical conductive contacts between the sensor and thePCB. In contrast, the presently disclosed sensor contacts(s) 3822provide a direct connection between the sensor 3716 and the PCB 3804connection, which eliminates the need for the prior art connector andadvantageously reduces the height H (FIG. 37B). Moreover, eliminatingthe compliant carbon impregnated polymer modules eliminates asignificant circuit resistance and therefor improves circuitconductivity.

The sensor control device 3702 may further include a compliant member3826, which may be arranged to interpose the flag 3818 and the innersurface of the shell 3706. More specifically, when the shell 3706 andthe mount 3708 are assembled to one another, the compliant member 3826may be configured to provide a passive biasing load against the flag3818 that forces the sensor contact(s) 3822 into continuous engagementwith the corresponding circuitry contact(s) 3824. In the illustratedembodiment, the compliant member 3826 is an elastomeric O-ring, butcould alternatively comprise any other type of biasing device ormechanism, such as a compression spring or the like, without departingfrom the scope of the disclosure.

The sensor control device 3702 may further include one or moreelectromagnetic shields, shown as a first shield 3828 a and a secondshield 3828 b. The shields 3828 a,b may be arranged between the shell3706 and the mount 3708; i.e., within the electronics housing 3704(FIGS. 37A-37B). In the illustrated embodiment, the first shield 3828 ais arranged above the PCB 3804 such that it faces the top surface of thePCB 3804, and the second shield 3828 b is arranged below the PCB 3804such that it faces the bottom surface of the PCB 3804.

The shields 3828 a,b may be configured to protect sensitive electroniccomponents from radiation while the sensor control device 3702 issubjected to radiation sterilization. More specifically, at least one ofthe shields 3828 a,b may be positioned to interpose the data processingunit 3808 and a radiation source, such as an e-beam electronaccelerator. In some embodiments, for example, at least one of theshields 3828 a,b may be positioned adjacent to and otherwise alignedwith the data processing unit 3808 and the radiation source to block ormitigate radiation absorbed dose that might otherwise damage thesensitive electronic circuitry of the data processing unit 3808.

In the illustrated embodiment, the data processing unit 3808 interposesthe first and second shields 3828 a,b such that the first and secondshields 3828 a,b essentially bookend the data processing unit 3808 inthe axial direction. In at least one embodiment, however, only one ofthe shields 3828 a,b may be necessary to properly protect the dataprocessing unit 3808 during radiation sterilization. For example, if thesensor control device 3702 is subjected to radiation sterilizationdirected toward the bottom of the mount 3708, only the second shield3828 b may be needed to interpose the data processing unit 3808 and theradiation source, and the first shield 3828 a may be omitted.Alternatively, if the sensor control device 3702 is subjected toradiation sterilization directed toward the top of the shell 3706, onlythe first shield 3828 a may be needed to interpose the data processingunit 3808 and the radiation source, and the second shield 3828 b may beomitted. In other embodiments, however, both shields 3828 a,b may beemployed, without departing from the scope of the disclosure.

The shields 3828 a,b may be made of any material capable of attenuating(or substantially attenuating) the transmission of radiation. Suitablematerials for the shields 3828 a,b include, but are not limited to,lead, tungsten, iron-based metals (e.g., stainless steel), copper,tantalum, tungsten, osmium, aluminum, carbon, or any combinationthereof. Suitable metals for the shields 3828 a,b may becorrosion-resistant, austenitic, and any non-magnetic metal with adensity ranging between about 2 grams per cubic centimeter (g/cc) andabout 23 g/cc. The shields 3828 a,b may be fabricated via a variety ofmanufacturing techniques including, but not limited to, stamping,casting, injection molding, sintering, two-shot molding, or anycombination thereof.

In other embodiments, however, the shields 3828 a,b may comprise ametal-filled thermoplastic polymer such as, but not limited to,polyamide, polycarbonate, or polystyrene. In such embodiments, theshields 3828 a,b may be fabricated by mixing the shielding material inan adhesive matrix and dispensing the combination onto shaped componentsor otherwise directly onto the data processing unit 3808. Moreover, insuch embodiments, the shields 3828 a,b may comprise an enclosure thatencapsulates (or substantially encapsulates) the data processing unit3808. In such embodiments, the shields 3828 a,b may comprise ametal-filled thermoplastic polymer, as mentioned above, or mayalternatively be made of any of the materials mentioned herein that arecapable of attenuating (or substantially attenuating) the transmissionof radiation.

The shell 3706 may provide or otherwise define a first clockingreceptacle 3830 a (FIG. 38B) and a second clocking receptacle 3830 b(FIG. 38B), and the mount 3708 may provide or otherwise define a firstclocking post 3832 a (FIG. 38A) and a second clocking post 3832 b (FIG.38A). Mating the first and second clocking receptacles 3830 a,b with thefirst and second clocking posts 3832 a,b, respectively, will properlyalign the shell 3706 to the mount 3708.

Referring specifically to FIG. 38A, the inner surface of the mount 3708may provide or otherwise define a plurality of pockets or depressionsconfigured to accommodate various component parts of the sensor controldevice 3702 when the shell 3706 is mated to the mount 3708. For example,the inner surface of the mount 3708 may define a battery locator 3834configured to accommodate a portion of the battery 3812 when the sensorcontrol device 3702 is assembled. An adjacent contact pocket 3836 may beconfigured to accommodate a portion of the axial contact 3814 a.

Moreover, a plurality of module pockets 3838 may be defined in the innersurface of the mount 3708 to accommodate the various electronic modules3806 arranged on the bottom of the PCB 3804. Furthermore, a shieldlocator 3840 may be defined in the inner surface of the mount 3708 toaccommodate at least a portion of the second shield 3828 b when thesensor control device 3702 is assembled. The battery locator 3834, thecontact pocket 3836, the module pockets 3838, and the shield locator3840 all extend a short distance into the inner surface of the mount3708 and, as a result, the overall height H (FIG. 37B) of the sensorcontrol device 3702 may be reduced as compared to prior sensor controldevices. The module pockets 3838 may also help minimize the diameter ofthe PCB 3804 by allowing PCB components to be arranged on both sides(i.e., top and bottom surfaces).

Still referring to FIG. 38A, the mount 3708 may further include aplurality of carrier grip features 3842 (two shown) defined about theouter periphery of the mount 3708. The carrier grip features 3842 areaxially offset from the bottom 3844 of the mount 3708, where a transferadhesive (not shown) may be applied during assembly. In contrast toprior sensor control devices, which commonly include conical carriergrip features that intersect with the bottom of the mount, the presentlydisclosed carrier grip features 3842 are offset from the plane (i.e.,the bottom 3844) where the transfer adhesive is applied. This may proveadvantageous in helping ensure that the delivery system does notinadvertently stick to the transfer adhesive during assembly. Moreover,the presently disclosed carrier grip features 3842 eliminate the needfor a scalloped transfer adhesive, which simplifies the manufacture ofthe transfer adhesive and eliminates the need to accurately clock thetransfer adhesive relative to the mount 3708. This also increases thebond area and, therefore, the bond strength.

Referring to FIG. 38B, the bottom 3844 of the mount 3708 may provide orotherwise define a plurality of grooves 3846, which may be defined at ornear the outer periphery of the mount 3708 and equidistantly spaced fromeach other. A transfer adhesive (not shown) may be coupled to the bottom3844 and the grooves 3846 may be configured to help convey (transfer)moisture away from the sensor control device 3702 and toward theperiphery of the mount 3708 during use. In some embodiments, the spacingof the grooves 3846 may interpose the module pockets 3838 (FIG. 38A)defined on the opposing side (inner surface) of the mount 3708. As willbe appreciated, alternating the position of the grooves 3846 and themodule pockets 3838 ensures that the opposing features on either side ofthe mount 3708 do not extend into each other. This may help maximizeusage of the material for the mount 3708 and thereby help maintain aminimal height H (FIG. 37B) of the sensor control device 3702. Themodule pockets 3838 may also significantly reduce mold sink, and improvethe flatness of the bottom 3844 that the transfer adhesive bonds to.

Still referring to FIG. 38B, the inner surface of the shell 3706 mayalso provide or otherwise define a plurality of pockets or depressionsconfigured to accommodate various component parts of the sensor controldevice 3702 when the shell 3706 is mated to the mount 3708. For example,the inner surface of the shell 3706 may define an opposing batterylocator 3848 arrangeable opposite the battery locator 3834 (FIG. 38A) ofthe mount 3708 and configured to accommodate a portion of the battery3812 when the sensor control device 3702 is assembled. Moreover, ashield locator 3850 may be defined in the inner surface of the shell3706 to accommodate at least a portion of the first shield 3828 a whenthe sensor control device 3702 is assembled. The opposing batterylocator 3848 and the shield locator 3850 extend a short distance intothe inner surface of the shell 3706, which helps reduce the overallheight H (FIG. 37B) of the sensor control device 3702.

A sharp and sensor locator 3852 may also be provided by or otherwisedefined on the inner surface of the shell 3706. The sharp and sensorlocator 3852 may be configured to receive both the sharp (not shown) anda portion of the sensor 3716. Moreover, the sharp and sensor locator3852 may be configured to align and/or mate with a corresponding sharpand sensor locator 2054 (FIG. 38A) provided on the inner surface of themount 3708.

FIGS. 39A-39D show progressive example assembly of the sensor controldevice 3702, according to one or more embodiments. In FIG. 39A, thebattery 3812 has been loaded into the opposing battery locator 3848 andthe first shield 3828 a has been loaded into the shield locator 3850defined in the inner surface of the shell 3706. The compliant member3826 and the flag 3818 of the sensor 3716 may each be mounted to thefirst clocking receptacle 3830 a. The tail 3816 of the sensor 3716 maybe inserted into the sharp and the sensor locator 3852.

In FIG. 39B, the PCB 3804 may be loaded into the shell 3706 to align thebattery aperture 3810 with the battery 3812 and the axial and radialbattery contacts 3814 a,b facilitate electrical communication.

In FIG. 39C, the second shield 3828 b has been loaded into the shieldlocator 3840 defined in the inner surface of the mount 3708. The mount3708 is now ready to be coupled to the shell 3706 (FIGS. 39A and 39B).To accomplish this, the first and second clocking receptacles 3830 a,b(FIG. 39B) of the shell 3706 may be coaxially aligned with the first andsecond clocking posts 3832 a,b of the mount 3708, respectively. Anadhesive may be applied to one or both of the shell 3706 and the mount3708 to secure the two components together. In one embodiment, forexample, the adhesive may be applied around the outer diameter(periphery) of the shell 3706, and the shell 3706 may then betransferred to the mount 3708 and mated with the corresponding outerdiameter (periphery) of the mount 3708. In other embodiments, theadhesive may be applied around the outer diameter (periphery) of themount 3708 or the outer diameter (periphery) of both the shell 3706 andthe mount 3708, without departing from the scope of the disclosure. Inat least one embodiment, an adhesive may be used to secure the first andsecond clocking receptacles 3830 a,b to the first and second clockingposts 3832 a,b, respectively.

FIG. 39D shows the assembled sensor control device 3702, which may betested to ensure the sensor 3716 and the corresponding electronics ofthe sensor control device 3702 function properly. The adhesive may notonly secure the shell 3706 to the mount 3708 and provide structuralintegrity, but may also seal the interface between the two componentsand thereby isolate the interior of the electronics housing 3704 fromoutside contamination. Consequently, there may be no need to sterilizethe internal electrical components of the sensor control device 3702 viagaseous chemical sterilization (e.g., ethylene oxide). Rather, theadhesive provides a sterile and moisture barrier to the interior of theassembled sensor control device 3702.

The adhesive patch 3710 may be applied to the bottom 3844 of the mount3708. In some embodiments, the adhesive patch 3710 may have a removablerelease liner that is removed to enable the adhesive patch 3710 to beattached to the bottom 3844 of the mount 3708.

Either before or after securing the adhesive patch 3710, a sharp module3904 may be coupled to the sensor control device 3702. As illustrated,the sharp module 3904 may include a sharp hub 3906 and a sharp 3908carried by the sharp hub 3906 and extending through the electronicshousing 3704. To couple the sharp module 3904 to the sensor controldevice 3702, a sharp tip 3910 of the sharp 3908 may be extended throughthe coaxially aligned central apertures 3714, 3720 (FIGS. 37A and 37C)of the shell 3706 and the mount 3708, respectively. As the sharp tip3910 penetrates the sensor control device 3702, the tail 3816 may bereceived within a hollow or recessed portion of the sharp tip 3910. Thesharp tip 3910 may be configured to penetrate the skin while carryingthe tail 3816 to put the active chemistry present on the tail 3816 intocontact with bodily fluids.

The sharp tip 3910 may be advanced through the sensor control device3702 until the sharp hub 3906 engages the upper surface of the shell3706. As illustrated, the sharp hub 3906 may include a hub smallcylinder 3912 and a hub snap pawl 3914, each of which may be configuredto help couple the sensor control device 3702 to a sensor applicator(e.g., the sensor applicator 102 of FIG. 1).

FIGS. 40A and 40B are side and cross-sectional side views, respectively,of the sensor applicator 102 sealed with the applicator cap 210.According to the present disclosure, and as seen in FIG. 40B, the sensorcontrol device 3702 may already be assembled, as generally describedabove, and installed within the sensor applicator 102 prior to beingdelivered to a user. Accordingly, FIGS. 40A-40B depict how the sensorapplicator 102 might be shipped to and received by the user.

The applicator cap 210 may be configured to provide a barrier againstoutside contamination, and thereby maintains a sterile environment forthe assembled sensor control device 3702 positioned within the sensorapplicator 102. The applicator cap 210 may also create a dust-freeenvironment during shipping and storage that prevents the adhesive patch3710 (FIG. 40B) from becoming dirty. The applicator cap 210 may bethreaded to the housing 208 and include a tamper ring 4002. Uponrotating (e.g., unscrewing) the applicator cap 210 relative to thehousing 208, the tamper ring 4002 may shear and thereby free theapplicator cap 210 from the sensor applicator 102.

As shown in FIG. 40B, the sensor 3716 and the sharp 3908 are alreadyincorporated into the assembled sensor control device 3702.Consequently, there is no need for a two-piece architecture system thatrequires the sensor tray 202 (FIG. 2) or a user to finally assemble thesensor control device 3702 as shown in and described with reference toFIGS. 2A-2D. Rather, according to the present disclosure, the sensorcontrol device 3702 may be fully sterilized while loaded in the sensorapplicator 102 prior to being packaged for shipment to a user.

More specifically, the sensor control device 3702 may be subjected toradiation sterilization 4004 while loaded (positioned) within the sensorapplicator 102 to sterilize the sensor 3716 and the sharp 3908. Theradiation sterilization 4004 may comprise, for example, e-beamirradiation, but other methods of sterilization may alternatively beused including, but not limited to, gamma ray irradiation, low energyX-ray irradiation, or any combination thereof.

In some embodiments, as illustrated, the radiation sterilization 4004may be applied to the sensor control device 3702 through the applicatorcap 210 and otherwise through a proximal end 4006 of the applicator cap210. The applicator cap 210 may be made of any material that allowsradiation to pass therethrough. In at least one embodiment, for example,cap 210 may be made of a thermoplastic. The radiation sterilization 4004may propagate through the applicator cap 210 and impinge upon the sensorcontrol device 3702 to inactivate or kill microorganisms or othercontaminants that may be present on the sensor 3716 and the sharp 3908.

In some embodiments, the radiation sterilization 4004 may compriseelectron beam (e-beam) irradiation. E-beam irradiation is a penetratingprocess that allows the sensor control device 3702 to be already mountedwithin the sensor applicator 102 before the irradiation process. Bysterilizing the sensor control device 3702 after it has been packaged,the possibility of contamination during the time between sterilizationand packaging is reduced.

FIGS. 41A and 41B are enlarged cross-sectional views of the sensorcontrol device 3702 during example radiation sterilization 4004,according to one or more embodiments of the present disclosure. In oneaspect, one or more e-beam accelerators may be used to generate theradiation sterilization 4004 and, more particularly, to accelerateelectrons into a concentrated highly charged electron stream. Asmaterials pass through the stream of electrons, energy from the streamis absorbed and the absorption of this energy alters chemical andbiological bonds. At certain levels of absorption, also known as the“absorbed dose,” DNA chains and reproductive cells of microorganisms aredestroyed, and thereby effectively sterilizing the target device orpackage. The irradiation dosage is important, as too low of a dosage maynot result in complete sterilization, while too high of a dosage mayresult in adverse effects on the materials of the sensor control device3702 and the packaging (the applicator cap 210 of FIG. 40B) beingsterilized.

The electromagnetic shields 3828 a,b included within the sensor controldevice 3702 may prove advantageous in shielding and otherwise protectingsensitive electronic components, such as the data processing unit 3808,while the sensor control device 3702 is subjected to the radiationsterilization 4004.

In FIG. 41A, one or both of the first and second shields 3828 a,b mayhelp shield the data processing unit 3808 from the absorbed dose ofradiation from the radiation sterilization 4004. More specifically, theelectromagnetic shields 3828 a,b may be aligned with and otherwisepositioned to block or otherwise mitigate radiation exposure that mightotherwise damage the data processing unit 3808. In the illustratedembodiment, the radiation energy of the radiation sterilization 4004propagates normal to the data processing unit 3808, and at least thesecond shield 3828 b interposes the data processing unit 3808 and thesource of the radiation sterilization 4004.

In FIG. 41B, the first shield 3828 a covers and otherwise encapsulatesthe data processing unit 3808 and thereby helps shield the dataprocessing unit 3808 from the absorbed dose of radiation from theradiation sterilization 4004. More specifically, by forming an enclosurearound the data processing unit 3808, the first shield 3828 a may bepositioned to block or otherwise mitigate radiation exposure that mightotherwise damage the data processing unit 3808. In such embodiments, thesecond shield 3828 b may not be necessary.

The e-beam irradiation process of the radiation sterilization 4004 mayinclude a continuous exposure or an intermittent exposure, and thee-beam accelerator may be of a continuous or a varying power, dependingupon available machinery and determinations to achieve the desiredinternal and surface dosage limitations. The penetration power of e-beamirradiation correlates to the density of the underlying material beingsubjected to the radiation sterilization 4004 and the energy level ofthe e-beam accelerator. The larger and denser the material, the higherthe energy the e-beam accelerator must output to achieve fullpenetration.

FIG. 42 is a plot 4200 that graphically depicts an approximation ofpenetration depth as a function of the energy level of e-beam radiationsterilization for unit density materials such as water. As indicated bythe plot 4200, the higher the energy level of the electrons of thee-beam radiation sterilization, the deeper the radiation will penetrateinto a selected material. Most standard e-beam sterilization processesoperate at a 10 mega electron-volt (MeV) energy level which, accordingto the plot 4200, will penetrate into a given material about 3.8 cm fora unit density material such as water (density=1 g/cc).

According to embodiments of the present disclosure, e-beam sterilization(e.g., the radiation sterilization 4004 of FIGS. 40B and 41A-41B) may beundertaken at lower energy levels and nonetheless achieve comparable orcommensurate sterilization dose achieved at high energy levels (e.g., 10MeV or more). In some embodiments, for example, radiation sterilizationmay be undertaken at an energy level ranging between about 0.5 MeV andabout 3.0 MeV and can achieve an equivalent dose to irradiating athigher energy levels. In yet other embodiments, the radiationsterilization may be undertaken at an energy level as low as 0.1 MeV,without departing from the scope of the disclosure.

According to the plot 4200, dosing at an energy level ranging betweenabout 0.5 MeV and about 3.0 MeV equates to a penetration depth rangingbetween about 0.2 cm and about 1.0 cm for a material with density of 1g/cc. Accordingly, at lower energy levels, it may be possible to shieldsensitive electronic components with high density materials and smallthicknesses such that little or no radiation penetrates the shield.

In view of the foregoing, the material and configuration of the shields3828 a,b (FIGS. 41A-41B) may be selected and optimized (tuned) in viewof low energy radiation sterilization to protect the data processingunit 3808 (FIGS. 41A-41B). The penetration depth for a given materialmay be determined for example in the range of 0.2 to 2.0 MeV, byEquation (1) below obtained from ISO/ASTM 51649: 2005(E) “StandardPractice for Dosimetry in an Electron Beam Facility for RadiationProcessing at Energies between 300 keV and 25 MeV.”

$\begin{matrix}{{Rp} = \frac{( {{{0.5}07E} - {{0.1}243}} )}{\rho}} & {{Equation}\mspace{14mu}(1)}\end{matrix}$

where “E” is the energy level (MeV) of the e-beam accelerator and “p” isthe density (g/cm³) of the given material. Equation 1 is derived from aMonte Carlo simulation for one-sided irradiation through polystyrene. Assuch, the computed penetration depth is an approximate value forpolymeric and higher density materials. Based on the foregoing equation,Table 1 lists various materials that may be candidate materials for theshields 3828 a,b, their respective densities in g/cc, and theircalculated penetration depth Rp at energy levels E of 1 MeV, 2 MeV, and5 MeV:

TABLE 1 Penetration Depth (mm) Element Density (g/cc) 1 MeV 2 MeV 5 MeVCarbon 2.3 1.69 3.94 10.67 Aluminum 2.7 1.42 3.30 8.93 Iron 7.9 0.491.13 3.06 Stainless Steel 8.1 0.47 1.10 2.99 Copper 8.9 0.43 1.00 2.71Lead 11.4 0.34 0.78 2.12 Tantalum 16.7 0.23 0.53 1.45 Tungsten 19.4 0.200.46 1.25 Osmium 22.6 0.17 0.39 1.07

As indicated in Table 1, the higher the density of the material, thelower the penetration depth and, consequently, the thinner the materialcan be to adequately shield sensitive electronic components at lowerenergy levels. Moreover, the thinner the shield material, the thinnerthe product (e.g., the sensor control device 3702) can be.

According to one or more embodiments of the present disclosure, theshields 3828 a,b that protect the data processing unit 3808 fromradiation exposure may be any non-magnetic metal with a density of atleast 2.0 g/cc. In other embodiments, the shields 3828 a,b may be anon-magnetic metal with a density of at least 5.0 g/cc. According toTable 1, suitable materials for the shields 3828 a,b can include, butare not limited to, iron, stainless steel, copper, lead, tantalum,tungsten, and osmium. Because of its low cost and availability,stainless steel may be a preferred material. In some embodiments, thematerial for the shields 3828 a,b may be any non-magnetic metal with adensity ranging between about 2.0 g/cc and about 23.0 g/cc. In otherembodiments, the material for the shields 3828 a,b may be a non-magneticmetal with a density ranging between about 5.0 g/cc and about 15.0 g/cc.

In other embodiments, the shields 3828 a,b that protect the dataprocessing unit 3808 from radiation exposure may be a metal-filledthermoplastic polymer where the shielding metal exhibits a density of atleast 2.0 g/cc. In such embodiments, the metal-filled thermoplasticpolymer may be, but not limited to, polyamide, polycarbonate, orpolystyrene. In such embodiments, the shields 3828 a,b may be fabricatedby mixing the shielding material (metal) in an adhesive matrix anddispensing the combination onto shaped components or otherwise directlyonto the data processing unit 3808. Moreover, in such embodiments, theshield(s) 3828 a,b may comprise an enclosure that encapsulates (orsubstantially encapsulates) the data processing unit 3808.

FIG. 43 is a cross-sectional view of the sensor control device 3702mounted within the sensor applicator 102 with the applicator cap 210secured thereto, according to one or more additional embodiments.Similar to the embodiments of FIGS. 41A-41B, one or more shields may beused to protect sensitive electronic components of the sensor controldevice 3702. Unlike the embodiments of FIGS. 41A-41B, however, theshields of FIG. 43 are magnetic shields configured to divert propagatingradiation from the radiation sterilization 4004 (FIGS. 40B and 41A-41B)away from or otherwise around the data processing unit 3808.

More specifically, it is possible to locally deflect an electron beamaway from a component of interest, such as the data processing unit3808, by generating a static magnetic field. Charged particlesexperience a force when travelling through a magnetic field, and thedirection of this force is perpendicular to the direction of the fieldand the velocity of the charge. In equation form, a particle with mass mand charge q moving with velocity v in a magnetic field B experiences aforce characterized by the following equation:

F=qv×B  Equation (2)

This is a vector equation which indicates that the magnitude of theforce F is:

F=(qvB)sinθ  Equation (3)

where θ is the angle between the velocity v and the magnetic field B,and the direction of the force is perpendicular to both the velocity vand the magnetic field B (in a sense given by the right hand rule). Anelectron (charge −e) injected into a uniform magnetic field B and movingperpendicular to the field B experiences a force:

F=−evB  Equation (4)

Now the force F remains perpendicular to the velocity v and the electronmoves in a circular path of radius R. The radial (centripetal)acceleration is then:

$\begin{matrix}{a = {- \frac{v^{2}}{R}}} & {{Equation}\mspace{14mu}(5)}\end{matrix}$

Now apply Newton's second law of motion:

$\begin{matrix}{F = {m\; a}} & {{Equation}\mspace{14mu}(6)} \\{{e\; v\; B} = {m\frac{v^{2}}{R}}} & {{Equation}\mspace{14mu}(7)}\end{matrix}$

Thus, the radius R of the electron's path is:

$\begin{matrix}{R = \frac{mv}{eB}} & {{Equation}\mspace{20mu}(8)}\end{matrix}$

Accordingly, an electron having a mass m with a charge e and travelingat a velocity v through a magnetic field B, perpendicular to thedirection of the velocity v, will be deflected in a circle of radius Rand at a tangent to this circle once outside the influence of themagnetic field B. The magnetic field may be placed (generated) anywherealong the path of the propagating radiation (e.g., the e-beam) before itcan strike the component of interest (e.g., the data processing unit3808).

In one embodiment, a first magnet 4302 a may be arranged within theelectronics housing 3704 adjacent the data processing unit 3808 togenerate a static magnetic field. In the illustrated embodiment, thefirst magnet 4302 a is arranged where the second shield 3828 b of FIGS.41A-41B was placed. In such embodiments, a propagating radiation beam4304 (e.g., e-beam) may pass through the first magnet 4302 a and thestatic magnetic field generated by the first magnet 4302 a will causethe radiation beam 4304 to be diverted away from the data processingunit 3808.

In another embodiment, or in addition thereto, a second magnet 4302 bmay be arranged within the applicator cap 210 to generate a staticmagnetic field. In the illustrated embodiment, the second magnet 4302 bis positioned to interpose the radiation source (e.g., an e-beamaccelerator) and the data processing unit 3808. A propagating radiationbeam 4306 (e.g., e-beam) may pass through the second magnet 4302 b andthe static magnetic field generated by the second magnet 4302 b willcause the radiation beam 4306 to be diverted away from the dataprocessing unit 3808.

In yet other embodiments, or in addition thereto, a third magnet 4302 cmay be arranged external to the applicator cap 210 and the sensorapplicator 102 to generate a static magnetic field. In the illustratedembodiment, the third magnet 4302 c is positioned outside of theapplicator cap 210 and otherwise interposes the radiation source (e.g.,an e-beam accelerator) and the data processing unit 3808. A propagatingradiation beam 4308 (e.g., e-beam) may pass through the third magnet4302 c and the static magnetic field generated by the third magnet 4302c will cause the radiation beam 4308 to be diverted away from the dataprocessing unit 3808.

As will be appreciated, precise alignment of the magnets 4302 a-crelative to sensor control device 3702 would need to be taken intoconsideration and sufficient margin be applied to the location and fieldstrength accordingly.

Embodiments disclosed herein include:

Q. A sensor control device that includes an electronics housing, aprinted circuit board positioned within the electronics housing andhaving a data processing unit mounted thereto, a sensor extending from abottom of the electronics housing, a sharp module removably coupled tothe electronics housing and having a sharp that extends through theelectronics housing and receives a portion of the sensor extending fromthe bottom of the electronics housing, and at least one shieldpositioned within the electronics housing to protect the data processingunit from radiation from a radiation sterilization process.

R. An analyte monitoring system that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing, a printed circuit board positionedwithin the electronics housing and having a data processing unit mountedthereto, a sensor extending from a bottom of the electronics housing, asharp module removably coupled to the electronics housing and having asharp that extends through the electronics housing and receives aportion of the sensor extending from the bottom of the electronicshousing, and at least one shield positioned within the electronicshousing to protect the data processing unit from radiation from aradiation sterilization process. The analyte monitoring system furtherincluding a cap coupled to the sensor applicator to provide a barrierthat seals the sensor control device within the sensor applicator.

S. A method of preparing an analyte monitoring system including loadinga sensor control device into a sensor applicator, the sensor controldevice including an electronics housing, a printed circuit boardpositioned within the electronics housing and having a data processingunit mounted thereto, a sensor extending from a bottom of theelectronics housing, a sharp module removably coupled to the electronicshousing and having a sharp that extends through the electronics housingand receives a portion of the sensor extending from the bottom of theelectronics housing, and at least one shield positioned within theelectronics housing. The method further including securing a cap to thesensor applicator and thereby providing a barrier that seals the sensorcontrol device within the sensor applicator, sterilizing the sensor andthe sharp with radiation sterilization while the sensor control deviceis positioned within the sensor applicator, and shielding the dataprocessing unit with the at least one shield from radiation from theradiation sterilization.

T. A sensor control device that includes an electronics housing having ashell matable with a mount, a printed circuit board positioned withinthe electronics housing and defining a battery aperture sized to receivea battery, an axial battery contact extending into the battery apertureto provide electrical communication, and a radial battery contactextending into the battery aperture to provide electrical communication.

Each of embodiments Q, R, S, and T may have one or more of the followingadditional elements in any combination: Element 1: further comprising abattery aperture defined in the printed circuit board, a batteryreceived within the battery aperture, an axial battery contact coupledto the printed circuit board and extending into the battery aperture tofacilitate electrical communication, and a radial battery contactcoupled to the printed circuit board and extending into the batteryaperture to facilitate electrical communication. Element 2: furthercomprising one or more sensor contacts arranged on a flag of the sensor,and one or more circuitry contacts provided on the printed circuit boardand engageable with the one or more sensor contacts to facilitate directconnection between the sensor and the printed circuit board. Element 3:wherein the at least one shield interposes the data processing unit anda radiation source that facilitates radiation sterilization. Element 4:wherein the at least one shield comprises a first shield facing a bottomof the printed circuit board and a second shield facing a top of theprinted circuit board, and wherein the data processing unit interposesthe first and second shields. Element 5: wherein the at least one shieldcomprises an enclosure that encapsulates the data processing unit.Element 6: wherein the at least one shield is made of a non-magneticmetal that exhibits a density ranging between about 2 g/cc and about 23g/cc. Element 7: wherein the at least one shield is made ofthermoplastic polymer mixed with a non-magnetic metal having a densityof at least 2.0 g/cc. Element 8: further comprising a plurality ofelectronic modules coupled to top and bottom surfaces of the printedcircuit board. Element 9: wherein the electronics housing comprises amount and the shell secured together and sealed with an adhesive.Element 10: wherein the at least one shield comprises a magnet arrangedto divert the radiation away from the data processing unit.

Element 11: wherein the at least one shield interposes the dataprocessing unit and a radiation source that facilitates radiationsterilization of the sensor and the sharp. Element 12: wherein the atleast one shield is made with a non-magnetic metal having a density ofat least 2.0 g/cc. Element 13: wherein the sensor control device issubjected to the radiation sterilization while positioned within thesensor applicator and at an energy level ranging between about 0.1 MeVand about 10.0 MeV. Element 14: wherein the at least one shieldcomprises a magnet arranged to divert the radiation away from the dataprocessing unit.

Element 15: wherein the at least one shield interposes the dataprocessing unit and a radiation source that facilitates the radiationsterilization, and wherein the at least one shield is made with anon-magnetic metal having a density of at least 2.0 g/cc, the methodfurther comprising undertaking the radiation sterilization at an energylevel ranging between about 0.1 MeV and about 10.0 MeV. Element 16:wherein the electronics housing comprises a shell matable with a mount,and wherein loading the sensor control device into the sensor applicatoris preceded by sealing the shell to the mount with an adhesive andthereby generating a sterile barrier. Element 17: wherein the at leastone shield comprises a magnet, and wherein shielding the data processingunit with the at least one shield comprises generating a static magneticfield with the magnet, and diverting the radiation away from the dataprocessing unit with the static magnetic field.

Element 18: further comprising a plurality of electronic modules coupledto top and bottom surfaces of the printed circuit board. Element 19:wherein a plurality of module pockets are defined in an inner surface ofthe mount to accommodate the plurality of electronic modules. Element20: wherein the mount and the shell are secured together and sealed withan adhesive. Element 21: wherein the shell defines a reference featureextending a short distance into an interior of the electronics housing.Element 22: further comprising an adhesive patch positioned on anunderside of the mount. Element 23: wherein the shell defines an angledouter periphery. Element 24: further comprising a sensor partiallyarranged within the electronics housing and having a flag with one ormore sensor contacts, and a compliant member arranged to interpose theflag and an inner surface of the shell and provide a passive biasingload against the flag to force the one or more sensor contacts intoengagement with a corresponding one or more circuitry contacts providedon the printed circuit board. Element 25: wherein the compliant membercomprises an elastomeric O-ring. Element 26: further comprising at leastone shield positioned within the electronics housing, and a shieldlocator defined in an inner surface of the shell or the mount toaccommodate at least a portion of the at least one shield. Element 27:wherein the at least one shield comprises a first shield and a secondshield, and wherein the shield locator comprises a first shield locatordefined in an inner surface of the shell to accommodate at least aportion of the first shield, and a second shield locator defined in aninner surface of the mount to accommodate at least a portion of thesecond shield. Element 28: further comprising one or more clockingreceptacles defined on one of the mount or the shell, and one or moreclocking posts defined on the other of the mount or the shell and sizedto be received within the one or more clocking receptacles to properlyalign the shell to the mount. Element 29: wherein a battery locator isdefined in an inner surface of at least one of the shell and the mountand sized to accommodate a portion of the battery. Element 30: whereinthe inner surface of the at least one of the shell and the mount furtherdefines a contact pocket adjacent the battery locator and sized toaccommodate a portion of the axial contact. Element 31: furthercomprising a plurality of carrier grip features defined about an outerperiphery of the mount and axially offset from a bottom of the mount.

By way of non-limiting example, exemplary combinations applicable to Q,R, S, and T include: Element 3 with Element 4; Element 12 with Element13; Element 18 and Element 19; Element 20 and Element 21; Element 24 andElement 25; Element 26 and Element 27; and Element 28 and Element 30.

One-Piece Analyte Monitoring Systems with Sensor Cap

Referring briefly again to FIGS. 1 and 2A-2G, for the two-piecearchitecture system, the sensor tray 202 and the sensor applicator 102are provided to the user as separate packages, thus requiring the userto open each package and finally assemble the system. In someapplications, the discrete, sealed packages allow the sensor tray 202and the sensor applicator 102 to be sterilized in separate sterilizationprocesses unique to the contents of each package and otherwiseincompatible with the contents of the other. More specifically, thesensor tray 202, which includes the plug assembly 207, including thesensor 110 and the sharp 220, may be sterilized using radiationsterilization, such as electron beam (or “e-beam”) irradiation.Radiation sterilization, however, can damage the electrical componentsarranged within the electronics housing of the sensor control device104. Consequently, if the sensor applicator 102, which contains theelectronics housing of the sensor control device 104, needs to besterilized, it may be sterilized via another method, such as gaseouschemical sterilization using, for example, ethylene oxide. Gaseouschemical sterilization, however, can damage the enzymes or otherchemistry and biologics included on the sensor 110. Because of thissterilization incompatibility, the sensor tray 202 and the sensorapplicator 102 are commonly sterilized in separate sterilizationprocesses and subsequently packaged separately, which requires the userto finally assemble the components for use.

According to embodiments of the present disclosure, the sensor controldevice 104 may be modified to provide a one-piece architecture that maybe subjected to sterilization techniques specifically designed for aone-piece architecture sensor control device. A one-piece architectureallows the sensor applicator 102 and the sensor control device 104 to beshipped to the user in a single, sealed package that does not requireany final user assembly steps. Rather, the user need only open onepackage and subsequently deliver the sensor control device 104 to thetarget monitoring location. The one-piece system architecture describedherein may prove advantageous in eliminating component parts, variousfabrication process steps, and user assembly steps. As a result,packaging and waste are reduced, and the potential for user error orcontamination to the system is mitigated.

FIG. 44 is a side view of an example sensor control device 4402,according to one or more embodiments of the present disclosure. Thesensor control device 4402 may be similar in some respects to the sensorcontrol device 104 of FIG. 1 and therefore may be best understood withreference thereto. Moreover, the sensor control device 4402 may replacethe sensor control device 104 and, therefore, may be used in conjunctionwith the sensor applicator 102 of FIG. 1, which may deliver the sensorcontrol device 4402 to a target monitoring location on a user's skin.

Unlike the sensor control device 104 of FIG. 1, however, the sensorcontrol device 4402 may comprise a one-piece system architecture notrequiring a user to open multiple packages and finally assemble thesensor control device 4402 prior to application. Rather, upon receipt bythe user, the sensor control device 4402 may already be fully assembledand properly positioned within the sensor applicator 102 (FIG. 1). Touse the sensor control device 4402, the user need only open one barrier(e.g., the applicator cap 210 of FIG. 2B) before promptly delivering thesensor control device 4402 to the target monitoring location for use.

As illustrated, the sensor control device 4402 includes an electronicshousing 4404 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing4404 may exhibit other cross-sectional shapes, such as ovoid orpolygonal, without departing from the scope of the disclosure. Theelectronics housing 4404 may be configured to house or otherwise containvarious electrical components used to operate the sensor control device4402. In at least one embodiment, an adhesive patch 4405 may be arrangedat the bottom of the electronics housing 4404. The adhesive patch 4405may be similar to the adhesive patch 108 of FIG. 1, and may thus helpadhere the sensor control device 4402 to the user's skin for use.

The electronics housing 4404 may include a shell 4406 and a mount 4408that is matable with the shell 4406. The shell 4406 may be secured tothe mount 4408 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, one or more mechanical fasteners (e.g.,screws), a gasket, an adhesive, or any combination thereof. In somecases, the shell 4406 may be secured to the mount 4408 such that asealed interface therebetween is generated. In such embodiments, a sealmember 4409, such as a gasket or an adhesive, may be positioned at ornear the outer diameter (periphery) of the shell 4406 and the mount4408, and securing the two components together may compress the sealmember 4409 and thereby generate a sealed interface. The seal member4409 secures the shell 4406 to the mount 4408 and provides structuralintegrity, but may also isolate the interior of the electronics housing4404 from outside contamination. If the sensor control device 4402 isassembled in a controlled environment, there may be no need toterminally sterilize the internal electrical components. Rather, thesealed interface may provide a sufficient sterile barrier for theassembled electronics housing 4404.

The sensor control device 4402 may further include a sensor 4410(partially visible) and a sharp 4412 (partially visible) used to helpdeliver the sensor 4410 transcutaneously under a user's skin duringapplication of the sensor control device 4402. As illustrated,corresponding portions of the sensor 4410 and the sharp 4412 extenddistally from the electronics housing 4404 and, more particularly, fromthe bottom of the mount 4408. The sharp 4412 may include a sharp hub4414 configured to secure and carry the sharp 4412. To couple the sharp4412 to the sensor control device 4402, the sharp 4412 may be advancedaxially through the electronics housing 4404 until the sharp hub 4414engages an upper portion of the shell 4406. As the sharp 4412 penetratesthe electronics housing 4404, the exposed portion of the sensor 4410 maybe received within a hollow or recessed (arcuate) portion of the sharp4412. The remaining portion of the sensor 4410 is arranged within theinterior of the electronics housing 4404.

The sensor control device 4402 may further include a sensor cap 4416, asshown exploded (detached). The sensor cap 4416 may be removably coupledto the sensor control device 4402 (e.g., the electronics housing 4404)at or near the bottom of the mount 4408. As illustrated, the sensor cap4416 may comprise a generally cylindrical and elongate body having afirst end 4418 a and a second end 4418 b opposite the first end 4418 a.The first end 4418 a may be open to provide access into an inner chamber4420 defined within the body. In contrast, the second end 4418 b may beclosed and may provide or otherwise define an engagement feature 4422.As described herein, the engagement feature 4422 may be configured tohelp the sensor cap 4416 mate with the cap (e.g., the applicator cap 210of FIG. 2B) of a sensor applicator (e.g., the sensor applicator 102 ofFIGS. 1 and 2A-2G) such that the sensor cap 4416 is removed from thesensor control device 4402 upon removing the cap from the sensorapplicator. While the engagement feature 4422 is shown at or near thesecond end 4418 b of the sensor cap 4416, the engagement feature 4422may alternatively be positioned at an intermediate location between thefirst and second ends 4418 a,b.

As discussed in more detail below, the sensor cap 4416 may provide asealed barrier surrounding and protecting the exposed portions of thesensor 4410 and the sharp 4412 from gaseous chemical sterilization. Thesensor cap 4416 helps form a sealed sub-assembly that can first besterilized using radiation sterilization, following which components ofthe sensor control device 4402 that are sensitive to radiationsterilization may be assembled to the sealed subassembly and thensubjected to gaseous chemical sterilization.

FIG. 45 is an exploded view of the sensor control device 4402, accordingto one or more embodiments. The shell 4406 and the mount 4408 operate asopposing clamshell halves that enclose or otherwise substantiallyencapsulate the various electronic components of the sensor controldevice 4402. The adhesive patch 4405 may be applied to a bottom 4501 ofthe mount 4408.

As illustrated, the shell 4406 may provide or otherwise define a sharpand sensor locator 4502 and a clocking receptacle 4504. The sharp andsensor locator 4502 may be configured to receive portions of both thesharp 4412 and the sensor 4410. Moreover, the sharp and sensor locator4502 may be configured to align with and be partially received within acentral aperture 4506 defined in the mount 4408. Similarly, the clockingreceptacle 4504 may be configured to align with and be received within aclocking post (not shown) defined on the inner surface of the mount4408. Mating the sharp and sensor locator 4502 with the central aperture4506, and simultaneously mating the clocking receptacle 4504 with theclocking post may help axially and rotationally align the shell 4406with the mount 4408.

In some embodiments, a first seal member 4508 a (i.e., the seal member4409 of FIG. 44) may be applied to one or both of the shell 4406 and themount 4408 to secure the two components together. As illustrated, thefirst seal member 4508 a may be applied around the outer diameter(periphery) of the shell 4406, the mount 4408, or both. In anotherembodiment, or in addition thereto, a second seal member 4508 b may beused to seal the interface between the sharp and sensor locator 4502 andthe central aperture 4506. More specifically, the second seal member4508 b may be configured to provide a sealed interface at an annularridge 4510 that circumscribes the sharp and sensor locator 4502. Whenthe shell 4406 and the mount 4408 are mated, the annular ridge 4510 mayjuxtapose an opposing surface defined on the bottom of the mount 4408,and the seal member 4508 b may facilitate a seal between the opposingstructures. The seal members 4508 a,b may comprise, for example, anadhesive or a gasket, and each may help secure the shell 4406 to themount 4408 and seal the interface between the two components, andthereby isolate the interior of the electronics housing 4404 (FIG. 44)from outside contamination.

The sensor control device 4402 may include a printed circuit board (PCB)4516 that may be arranged within the interior cavity formed by matingthe shell 4406 and the mount 4408. A data processing unit 4518 and abattery 4520 may be mounted to or otherwise interact with the PCB 4516.The data processing unit 4518 may comprise, for example, an applicationspecific integrated circuit (ASIC) configured to implement one or morefunctions or routines associated with operation of the sensor controldevice 4402. More specifically, the data processing unit 4518 may beconfigured to perform data processing functions, where such functionsmay include, but are not limited to, filtering and encoding of datasignals, each of which corresponds to a sampled analyte level of theuser. The data processing unit 4518 may also include or otherwisecommunicate with an antenna for communicating with the reader device 106(FIG. 1).

The battery 4520 may provide power to the sensor control device 4402and, more particularly, to the electronic components of the PCB 4516.While not shown in FIG. 45, other electronic modules or components maybe mounted to the PCB 4516 and may include, but are not limited to, oneor more resistors, transistors, capacitors, inductors, diodes, andswitches.

The sensor control device 4402 may provide or otherwise include a sealedsubassembly 4522 (outlined in dashed lines), which includes (among othercomponent parts) the shell 4406, the sensor 4410, the sharp 4412, andthe sensor cap 4416. As discussed in more detail below, the sealedsubassembly 4522 may help isolate the sensor 4410 and the sharp 4412within the inner chamber 4420 of the sensor cap 4416 during a gaseouschemical sterilization process, which might otherwise adversely affectthe chemistry provided on the sensor 4410.

As illustrated, the sensor 4410 may include a tail 4524, a flag 4526,and a neck 4528 that interconnects the tail 4524 and the flag 4526. Thetail 4524 may be configured to extend through the central aperture 4506of the mount 4408 to be transcutaneously received beneath a user's skin.Moreover, the tail 4524 may have an enzyme or other chemistry includedthereon to help facilitate analyte monitoring. The flag 4526 may includea generally planar surface having one or more sensor contacts 4530(three shown) configured to align with and engage a corresponding one ormore circuitry contacts (not shown) provided on the PCB 4516. In someembodiments, the sensor contacts 4530 may comprise a carbon impregnatedpolymer printed or otherwise digitally applied to the flag 4526.

In assembling the sealed subassembly, the flag 4526 may be received atthe clocking receptacle 4504 and the tail 4524 may be received withinthe sharp and sensor locator 4502. In some embodiments, a groove 4532may be defined in the annular ridge 4510 to receive and seat the neck4528, and may allow the neck 4528 to be sealed below and on top andthereby isolate the enzymes and other chemistry included on the tail4524.

The sensor control device 4402 may further include a compliant member4534 receivable by the clocking receptacle 4504 and arranged tointerpose the flag 4526 and the inner surface of the shell 4406. Thecompliant member 4534 may be configured to provide a passive biasingload against the flag 4526 that forces the sensor contacts 4530 intocontinuous engagement with the corresponding circuitry contacts on thePCB 4516. In the illustrated embodiment, the compliant member 4534 is anelastomeric O-ring, but could alternatively comprise any other type ofbiasing device or mechanism, such as a compression spring or the like.In other embodiments, however, the compliant member 4534 may form anintegral part of the shell 4406, such as being an overmolded orco-molded portion of the shell 4406.

The sharp 4412 may include a sharp tip 4536 extendable through thecoaxially aligned sharp and sensor locator 4502 and the central aperture4506 of the shell 4406 and the mount 4408, respectively. In someembodiments, as the sharp tip 4536 extends through the sensor controldevice 4402, the tail 4524 of the sensor 4410 may be received within ahollow or recessed portion of the sharp tip 4536. The sharp tip 4536 maybe configured to penetrate the skin while carrying the tail 4524 to putthe active chemistry of the tail 4524 into contact with bodily fluids.The sharp tip 4536 may be advanced through the sensor control device4402 until the sharp hub 4414 engages an upper surface of the shell4406. In some embodiments, the sharp hub 4414 may form a sealedinterface at the upper surface of the shell 4406.

In the illustrated embodiment, the sealed subassembly 4522 may furtherinclude a collar 4540 that provides or otherwise defines a column 4542and an annular shoulder 4544 extending radially outward from the column4542. In assembling the sealed subassembly 4522, at least a portion ofthe column 4542 may be received within the inner chamber 4420 of thesensor cap 4416 at the first end 4418 a. The sensor cap 4416 may beremovably coupled to the collar 4540 and separated from the collar 4540prior to delivering the sensor control device 4402 to the targetmonitoring location on the user's skin. In some embodiments, the sensorcap 4416 may be removably coupled to the collar 4540 via an interferenceor friction fit. In other embodiments, the sensor cap 4416 may bethreaded to the column 4542. In yet other embodiments, the sensor cap4416 may be removably coupled to the collar 4540 with a frangible member(e.g., a shear ring) or substance that may be broken with minimalseparation force (e.g., axial or rotational force). In such embodiments,for example, the sensor cap 4416 may be secured to the collar 4540 witha tag (spot) of glue or a dab of wax.

In some embodiments, a third seal member 4508 c may interpose theannular shoulder 4544 and the annular ridge 4510 to form a sealedinterface. In such embodiments, the third seal member 4508 c may alsoextend (flow) into the groove 4532 defined in the annular ridge 4510 andthereby seal about the neck 4528 of the sensor 4410. Similar to thefirst and second seal members 4508 a,b, the third seal member 4508 c maycomprise an adhesive or a gasket.

In some embodiments, however, the collar 4540 may be omitted from thesealed subassembly 4522 and the sensor cap 4416 may alternatively beremovably coupled to the sharp and sensor locator 4502. In suchembodiments, the sensor cap 4416 may be removably coupled to the sharpand sensor locator 4502 via an interference or friction fit, threading,with a frangible member or substance, or any combination thereof.

FIG. 46A is a cross-sectional side view of the assembled sealedsubassembly 4522 of FIG. 45, according to one or more embodiments. Toassemble the sealed subassembly 4522, the compliant member 4534 mayfirst be received about the clocking receptacle 4504 and the flag 4526of the sensor 4410 may subsequently be placed atop the compliant member4534 and also about the clocking receptacle 4504. Alternatively, thecompliant member 4534 may form part of the shell 4406 (e.g., co-molded,overmolded, etc.) at the clocking receptacle 4504, and the flag 4526 maybe arranged thereon. The tail 4524 of the sensor 4410 may be receivedwithin the sharp and sensor locator 4502, and the neck 4528 may beseated within the groove 4532 defined in the annular ridge 4510.

The collar 4540 may then be extended over the sharp and sensor locator4502 until the annular shoulder 4544 rests against the annular ridge4510. In some embodiments, the third seal member 4508 c may interposethe annular shoulder 4544 and the annular ridge 4510 to form a sealedinterface, and the third seal member 4508 c may also extend (flow) intothe groove 4532 to form a seal about the neck 4528. The sensor cap 4416may then be removably coupled to the collar 4540, as generally describedabove, such that portions of one or both of the collar 4540 and thesharp and sensor locator 4502 are received within the inner chamber4420. In some embodiments, however, the collar 4540 may be omitted andthe sensor cap 4416 may instead be received on the sharp and sensorlocator 4502 and the third seal member 4508 c may seal the interface(s)between the sensor cap 4416 and the sharp and sensor locator 4502.

Before or after assembling the sensor cap 4416, the sharp 4412 may becoupled to the sensor control device 4402 by extending the sharp tip4536 through an aperture 4602 defined in the top of the shell 4406 andadvancing the sharp 4412 through the sharp and sensor locator 4502 untilthe sharp hub 4414 engages a top surface of the shell 4406. In theillustrated embodiment, the top surface where the sharp hub 4414 engagesthe shell 4406 comprises a recessed portion of the shell 4406, but couldalternatively comprise an upper surface that is level with adjacentportions of the shell 4406.

The inner chamber 4420 may be sized and otherwise configured to receivethe tail 4524 and the sharp tip 4536. Moreover, the inner chamber 4420may be sealed to isolate the sensor 4410 from substances that mightadversely interact with the chemistry of the tail 4524. Morespecifically, the inner chamber 4420 may be sealed at the interfacebetween the hub 4414 and the shell 4406, at the interface between theannular shoulder 4544 and the annular ridge 4510 (e.g., with the thirdseal member 4508 c), and at the interface between the sensor cap 4416and the collar 4540 (e.g., via an interference fit or the like). In someembodiments, a desiccant 4603 may be present within the inner chamber4420 to maintain preferred humidity levels.

Once properly assembled, the sealed subassembly 4522 may be subjected toradiation sterilization to properly sterilize the sensor 4410 and thesharp 4412. Advantageously, this sterilization step may be undertakenapart from the other component parts of the sensor control device 4402(FIG. 45) since radiation sterilization can damage sensitive electricalcomponents associated with the PCB 4516 (FIG. 45), such as the dataprocessing unit 4518 (FIG. 45).

Suitable radiation sterilization processes include, but are not limitedto, electron beam (e-beam) irradiation, gamma ray irradiation, X-rayirradiation, or any combination thereof. In some embodiments, the sealedsubassembly 4522 may be subjected to radiation sterilization prior tocoupling the sensor cap 4416 to the collar 4540 (or the sharp and sensorlocator 4502). In other embodiments, however, the sealed subassembly4522 may be sterilized after coupling the sensor cap 4416 to the collar4540 (or the sharp and sensor locator 4502). In such embodiments, thebody of the sensor cap 4416 may comprise a material that permitspropagation of radiation therethrough to facilitate radiationsterilization of the distal portions of the sensor 4410 and the sharp4412. Suitable materials include, but are not limited to, a non-magneticmetal (e.g., aluminum, copper, gold, silver, etc.), a thermoplastic,ceramic, rubber (e.g., ebonite), a composite material (e.g., fiberglass,carbon fiber reinforced polymer, etc.), an epoxy, or any combinationthereof. In some embodiments, the sensor cap 4416 may be transparent ortranslucent, but can otherwise be opaque, without departing from thescope of the disclosure.

FIG. 46B is a cross-sectional side view of the fully assembled sensorcontrol device 4402, according to one or more embodiments. Onceassembled and properly sterilized, as discussed above, the sealedsubassembly 4522 of FIG. 46A may be assembled to the remaining componentparts of the sensor control device 4402. The PCB 4516 may be positionedwithin the shell 4406, and the mount 4408 may subsequently be secured tothe shell 4406. To axially and rotationally align the shell 4406 withthe mount 4408, the sensor cap 4416 may be aligned with and extendedthrough the central aperture 4506 of the mount 4408. The sharp andsensor locator 4502 may then be received within the central aperture4506, and the clocking receptacle 4504 may be mated with a clocking post4604 defined by the mount 4408.

As discussed above, the first and second seal members 4508 a,b may beused to secure the mount 4408 to the shell 4406 and also isolate theinterior of the electronics housing 4404 from outside contamination. Inthe illustrated embodiment, the second seal member 4508 b may interposethe annular shoulder 4544 of the collar 4540 and a portion of the mount4408 and, more particularly, the central aperture 4506. The adhesivepatch 4405 may then be applied to the bottom 4501 of the mount 4408.

FIGS. 47A and 47B are side and cross-sectional side views, respectively,of an example embodiment of the sensor applicator 102 with theapplicator cap 210 coupled thereto. More specifically, FIG. 47A depictshow the sensor applicator 102 might be shipped to and received by auser, and FIG. 47B depicts the sensor control device 4402 arrangedwithin the sensor applicator 102. Accordingly, the fully assembledsensor control device 4402 may already be assembled and installed withinthe sensor applicator 102 prior to being delivered to the user, thusremoving any additional assembly steps that a user would otherwise haveto perform.

The fully assembled sensor control device 4402 may be loaded into thesensor applicator 102, and the applicator cap 210 may subsequently becoupled to the sensor applicator 102. In some embodiments, theapplicator cap 210 may be threaded to the housing 208 and include atamper ring 4702. Upon rotating (e.g., unscrewing) the applicator cap210 relative to the housing 208, the tamper ring 4702 may shear andthereby free the applicator cap 210 from the sensor applicator 102.

According to the present disclosure, while loaded in the sensorapplicator 102, the sensor control device 4402 may be subjected togaseous chemical sterilization 4704 configured to sterilize theelectronics housing 4404 and any other exposed portions of the sensorcontrol device 4402. To accomplish this, a chemical may be injected intoa sterilization chamber 4706 cooperatively defined by the sensorapplicator 102 and the interconnected cap 210. In some applications, thechemical may be injected into the sterilization chamber 4706 via one ormore vents 4708 defined in the applicator cap 210 at its proximal end610. Example chemicals that may be used for the gaseous chemicalsterilization 4704 include, but are not limited to, ethylene oxide,vaporized hydrogen peroxide, nitrogen oxide (e.g., nitrous oxide,nitrogen dioxide, etc.), and steam.

Since the distal portions of the sensor 4410 and the sharp 4412 aresealed within the sensor cap 4416, the chemicals used during the gaseouschemical sterilization process do not interact with the enzymes,chemistry, and biologics provided on the tail 4524 and other sensorcomponents, such as membrane coatings that regulate analyte influx.

Once a desired sterility assurance level has been achieved within thesterilization chamber 4706, the gaseous solution may be removed and thesterilization chamber 4706 may be aerated. Aeration may be achieved by aseries of vacuums and subsequently circulating a gas (e.g., nitrogen) orfiltered air through the sterilization chamber 4706. Once thesterilization chamber 4706 is properly aerated, the vents 4708 may beoccluded with a seal 4712 (shown in dashed lines).

In some embodiments, the seal 4712 may comprise two or more layers ofdifferent materials. The first layer may be made of a synthetic material(e.g., a flash-spun high-density polyethylene fiber), such as Tyvek®available from DuPont®. Tyvek® is highly durable and puncture resistantand allows the permeation of vapors. The Tyvek® layer can be appliedbefore the gaseous chemical sterilization process, and following thegaseous chemical sterilization process, a foil or other vapor andmoisture resistant material layer may be sealed (e.g., heat sealed) overthe Tyvek® layer to prevent the ingress of contaminants and moistureinto the sterilization chamber 4706. In other embodiments, the seal 4712may comprise only a single protective layer applied to the applicatorcap 210. In such embodiments, the single layer may be gas permeable forthe sterilization process, but may also be capable of protection againstmoisture and other harmful elements once the sterilization process iscomplete.

With the seal 4712 in place, the applicator cap 210 provides a barrieragainst outside contamination, and thereby maintains a sterileenvironment for the assembled sensor control device 4402 until the userremoves (unthreads) the applicator cap 210. The applicator cap 210 mayalso create a dust-free environment during shipping and storage thatprevents the adhesive patch 4714 from becoming dirty.

FIG. 48 is a perspective view of an example embodiment of the applicatorcap 210, according to the present disclosure. As illustrated, theapplicator cap 210 is generally circular and defines a series of threads4802 used to couple the applicator cap 210 to the sensor applicator 102(FIGS. 47A and 47B). The vents 4708 discussed above are also visible inthe bottom of the applicator cap 210.

The applicator cap 210 may further provide and otherwise define a cappost 4804 centrally located within the interior of the applicator cap210 and extending proximally from the bottom thereof. The cap post 4804may be configured to receive the sensor cap 4416 (FIGS. 44, 45, 46A-46B)upon coupling the applicator cap 210 to the sensor applicator 102. Morespecifically, the cap post 4804 may define a receiver feature 4806configured to interact with (e.g., receive) the engagement feature 4422(FIG. 44) of the sensor cap 4416. Upon removing the applicator cap 210from the sensor applicator 102, however, the receiver feature 4806 mayretain the engagement feature 4422 and thereby prevent the sensor cap4416 from separating from the cap post 4804. Consequently, removing theapplicator cap 210 from the sensor applicator 102 will simultaneouslydetach the sensor cap 4416 from the sensor control device 4402 (FIG.47B), and thereby expose the distal portions of the sensor 4410 (FIG.47B) and the sharp 4412 (FIG. 47B).

As will be appreciated, many design variations of the engagement andreceiver features 4422, 4806 may be employed, without departing from thescope of the disclosure. Any design may be used that allows theengagement feature 4422 to be received by the receiver feature 4806 uponcoupling the applicator cap 210 to the sensor applicator 102, andsubsequently prevent the sensor cap 4416 from separating from the cappost 4804 upon removing the applicator cap 210. In some embodiments, forexample, the engagement and receiver features 4422, 4806 may comprise athreaded interface or a keyed mating profile that allows initialengagement but prevents subsequent disengagement.

In the illustrated embodiment, the receiver feature 4806 includes one ormore compliant members 4808 that are expandable or flexible to receivethe engagement feature 4422 (FIG. 44). The engagement feature 4422 maycomprise, for example, an enlarged head or define one or more radialprotrusions, and the compliant member(s) 4808 may comprise a collet-typedevice that includes a plurality of compliant fingers configured to flexradially outward to receive the enlarged head or radial protrusion(s).In other embodiments, however, the compliant member(s) 4808 may comprisean elastomer or another type of compliant material configured to expandradially to receive the enlarged head or radial protrusion(s).

FIG. 49 is a cross-sectional side view of the sensor control device 4402positioned within the applicator cap 210, according to one or moreembodiments. In the illustrated depiction, the remaining portions of thesensor applicator 102 (FIGS. 47A-47B) are omitted for simplicity. Asillustrated, the opening to the receiver feature 4806 exhibits a firstdiameter D₁, while the engagement feature 4422 of the sensor cap 4416exhibits a second diameter D₂ that is larger than the first diameter D₁and greater than the outer diameter of the remaining portions of thesensor cap 4416. Accordingly, as the sensor cap 4416 is extended intothe cap post 4804, the compliant member(s) 4808 may flex (expand)radially outward to receive the engagement feature 4422.

In some embodiments, the engagement feature 4422 may provide orotherwise define an angled outer surface that helps bias the compliantmember(s) 4808 radially outward. The engagement feature 4422, however,may also define an upper shoulder 4902 that prevents the sensor cap 4416from reversing out of the cap post 4804. More specifically, the shoulder4902 may comprise a sharp surface at the second diameter D₂ that willengage but not urge the compliant member(s) 4808 to flex radiallyoutward in the reverse direction.

Once the engagement feature 4422 bypasses the receiver feature 4806, thecompliant member(s) 4808 flex back to (or towards) their natural state.Upon removing the applicator cap 210 from the sensor applicator 102(FIGS. 47A-47B), the shoulder 4902 will engage and bind against thecompliant member(s) 4808, thereby separating the sensor cap 4416 fromthe sensor control device 4402 and exposing the distal portions of thesensor 4410 and the sharp 4412.

In some embodiments, the receiver feature 4806 may alternatively bethreaded and the engagement feature 4422 may also be threaded andconfigured to threadably engage the threads of the receiver feature4806. The sensor cap 4416 may be received within the cap post 4804 viathreaded rotation. Upon removing the applicator cap 210 from the sensorapplicator 102, the opposing threads on the engagement and receiverfeatures 4422, 4806 bind and the sensor cap 4416 may be separated fromthe sensor control device 4402.

FIGS. 50A and 50B are isometric and side views, respectively, of anotherexample sensor control device 5002, according to one or more embodimentsof the present disclosure. The sensor control device 5002 may be similarin some respects to the sensor control device 4402 of FIG. 44 andtherefore may be best understood with reference thereto. Moreover, thesensor control device 5002 may replace the sensor control device 104 ofFIG. 1 and, therefore, may be used in conjunction with the sensorapplicator 102 of FIG. 1, which may deliver the sensor control device5002 to a target monitoring location on a user's skin. Similar to thesensor control device 4402 of FIG. 44, the sensor control device 5002may comprise a one-piece architecture.

As illustrated, the sensor control device 5002 includes an electronicshousing 5004 that includes a shell 5006 and a mount 5008 that is matablewith the shell 5006. The shell 5006 may be secured to the mount 5008 viaa variety of ways, such as a snap fit engagement, an interference fit,sonic welding, one or more mechanical fasteners (e.g., screws), agasket, an adhesive, or any combination thereof. In some cases, theshell 5006 may be secured to the mount 5008 such that a sealed interfaceis generated therebetween.

The sensor control device 5002 may further include a sensor 5010(partially visible) and a sharp 5012 (partially visible), similar infunction to the sensor 4410 and the sharp 4412 of FIG. 44. Correspondingportions of the sensor 5010 and the sharp 5012 extend distally from thebottom of the electronics housing 5004 (e.g., the mount 5008). The sharp5012 may include a sharp hub 5014 configured to secure and carry thesharp 5012. As best seen in FIG. 50B, the sharp hub 5014 may include orotherwise define a mating member 5016. To couple the sharp 5012 to thesensor control device 5002, the sharp 5012 may be advanced axiallythrough the electronics housing 5004 until the sharp hub 5014 engages anupper surface of the shell 5006 and the mating member 5016 extendsdistally from the bottom of the mount 5008. As the sharp 5012 penetratesthe electronics housing 5004, the exposed portion of the sensor 5010 maybe received within a hollow or recessed (arcuate) portion of the sharp5012. The remaining portion of the sensor 5010 is arranged within theinterior of the electronics housing 5004.

The sensor control device 5002 may further include a sensor cap 5018,shown exploded or detached from the electronics housing 5004 in FIGS.50A-50B. Similar to the sensor cap 4416 of FIG. 44, the sensor cap 5018may help provide a sealed barrier that surrounds and protects theexposed portions of the sensor 5010 and the sharp 5012 from gaseouschemical sterilization. As illustrated, the sensor cap 5018 may comprisea generally cylindrical body having a first end 5020 a and a second end5020 b opposite the first end 5020 a. The first end 5020 a may be opento provide access into an inner chamber 5022 defined within the body. Incontrast, the second end 5020 b may be closed and may provide orotherwise define an engagement feature 5024. Similar to the engagementfeature 4422 of FIG. 44, the engagement feature 5024 may help mate thesensor cap 5018 to the cap (e.g., the applicator cap 210 of FIG. 2B) ofa sensor applicator (e.g., the sensor applicator 102 of FIGS. 1 and2A-2G), and may help remove the sensor cap 5018 from the sensor controldevice 5002 upon removing the cap from the sensor applicator.

The sensor cap 5018 may be removably coupled to the electronics housing5004 at or near the bottom of the mount 5008. More specifically, thesensor cap 5018 may be removably coupled to the mating member 5016,which extends distally from the bottom of the mount 5008. In at leastone embodiment, for example, the mating member 5016 may define a set ofexternal threads 5026 a (FIG. 50B) matable with a set of internalthreads 5026 b (FIG. 50A) defined by the sensor cap 5018. In someembodiments, the external and internal threads 5026 a,b may comprise aflat thread design (e.g., lack of helical curvature), which may proveadvantageous in molding the parts. Alternatively, the external andinternal threads 5026 a,b may comprise a helical threaded engagement.Accordingly, the sensor cap 5018 may be threadably coupled to the sensorcontrol device 5002 at the mating member 5016 of the sharp hub 5014. Inother embodiments, the sensor cap 5018 may be removably coupled to themating member 5016 via other types of engagements including, but notlimited to, an interference or friction fit, or a frangible member orsubstance that may be broken with minimal separation force (e.g., axialor rotational force).

In some embodiments, the sensor cap 5018 may comprise a monolithic(singular) structure extending between the first and second ends 5020a,b. In other embodiments, however, the sensor cap 5018 may comprise twoor more component parts. In the illustrated embodiment, for example, thesensor cap 5018 may include a seal ring 5028 positioned at the first end5020 a and a desiccant cap 5030 arranged at the second end 5020 b. Theseal ring 5028 may be configured to help seal the inner chamber 5022, asdescribed in more detail below. In at least one embodiment, the sealring 5028 may comprise an elastomeric O-ring. The desiccant cap 5030 mayhouse or comprise a desiccant to help maintain preferred humidity levelswithin the inner chamber 5022. The desiccant cap 5030 may also define orotherwise provide the engagement feature 5024 of the sensor cap 5018.

FIGS. 51A and 51B are exploded isometric top and bottom views,respectively, of the sensor control device 5002, according to one ormore embodiments. The shell 5006 and the mount 5008 operate as opposingclamshell halves that enclose or otherwise substantially encapsulatevarious electronic components of the sensor control device 5002. Theelectronic components housed within the electronics housing 5004 may besimilar to the electronic components described with reference to FIG. 45and, therefore, will not be described again. While not shown, the sensorcontrol device 5002 may also include an adhesive patch that may beapplied to the bottom 5102 (FIG. 51B) of the mount 5008, and may helpadhere the sensor control device 5002 to the user's skin for use.

The sensor control device 5002 may provide or otherwise include a sealedsubassembly that includes, among other component parts, the shell 5006,the sensor 5010, the sharp 5012, and the sensor cap 5018. Similar to thesealed subassembly 4522 of FIG. 45, the sealed subassembly of the sensorcontrol device 5002 may help isolate the sensor 5010 and the sharp 5012within the inner chamber 5022 (FIG. 51A) of the sensor cap 5018 during agaseous chemical sterilization process, which might otherwise adverselyaffect the chemistry provided on the sensor 5010.

The sensor 5010 may include a tail 5104 that extends out an aperture5106 (FIG. 51B) defined in the mount 5008 to be transcutaneouslyreceived beneath a user's skin. The tail 5104 may have an enzyme orother chemistry included thereon to help facilitate analyte monitoring.The sharp 5012 may include a sharp tip 5108 extendable through anaperture 5110 (FIG. 51A) defined by the shell 5006, and the aperture5110 may be coaxially aligned with the aperture 5106 of the mount 5008.As the sharp tip 5108 penetrates the electronics housing 5004, the tail5104 of the sensor 5010 may be received within a hollow or recessedportion of the sharp tip 5108. The sharp tip 5108 may be configured topenetrate the skin while carrying the tail 5104 to put the activechemistry of the tail 5104 into contact with bodily fluids.

The sharp tip 5108 may be advanced through the electronics housing 5004until the sharp hub 5014 engages an upper surface of the shell 5006 andthe mating member 5016 extends out the aperture 5106 in the bottom 5102of the mount 5008. In some embodiments, a seal member (not shown), suchas an O-ring or seal ring, may interpose the sharp hub 5014 and theupper surface of the shell 5006 to help seal the interface between thetwo components. In some embodiments, the seal member may comprise aseparate component part, but may alternatively form an integral part ofthe shell 5006, such as being a co-molded or overmolded component part.

The sealed subassembly may further include a collar 5112 that ispositioned within the electronics housing 5004 and extends at leastpartially into the aperture 5106. The collar 5112 may be a generallyannular structure that defines or otherwise provides an annular ridge5114 on its top surface. In some embodiments, as illustrated, a groove5116 may be defined in the annular ridge 5114 and may be configured toaccommodate or otherwise receive a portion of the sensor 5010 extendinglaterally within the electronics housing 5004.

In assembling the sealed subassembly, a bottom 5118 of the collar 5112may be exposed at the aperture 5106 and may sealingly engage the firstend 5020 a of the sensor cap 5018 and, more particularly, the seal ring5028. In contrast, the annular ridge 5114 at the top of the collar 5112may sealingly engage an inner surface (not shown) of the shell 5006. Inat least one embodiment, a seal member (not shown) may interpose theannular ridge 5114 and the inner surface of the shell 5006 to form asealed interface. In such embodiments, the seal member may also extend(flow) into the groove 5116 defined in the annular ridge 5114 andthereby seal about the sensor 5010 extending laterally within theelectronics housing 5004. The seal member may comprise, for example, anadhesive, a gasket, or an ultrasonic weld, and may help isolate theenzymes and other chemistry included on the tail 5104.

FIG. 52 is a cross-sectional side view of an assembled sealedsubassembly 5200, according to one or more embodiments. The sealedsubassembly 5200 may form part of the sensor control device 5002 ofFIGS. 50A-50B and 51A-51B and may include portions of the shell 5006,the sensor 5010, the sharp 5012, the sensor cap 5018, and the collar5112. The sealed subassembly 5200 may be assembled in a variety of ways.In one assembly process, the sharp 5012 may be coupled to the sensorcontrol device 5002 by extending the sharp tip 5108 through the aperture5110 defined in the top of the shell 5006 and advancing the sharp 5012through the shell 5006 until the sharp hub 5014 engages the top of theshell 5006 and the mating member 196 extends distally from the shell5006. In some embodiments, as mentioned above, a seal member 5202 (e.g.,an O-ring or seal ring) may interpose the sharp hub 5014 and the uppersurface of the shell 5006 to help seal the interface between the twocomponents.

The collar 5112 may then be received over (about) the mating member 5016and advanced toward an inner surface 5204 of the shell 5006 to enablethe annular ridge 5114 to engage the inner surface 5204. A seal member5206 may interpose the annular ridge 5114 and the inner surface 5204 andthereby form a sealed interface. The seal member 5206 may also extend(flow) into the groove 5116 (FIGS. 51A-51B) defined in the annular ridge5114 and thereby seal about the sensor 5010 extending laterally withinthe electronics housing 5004 (FIGS. 51A-51B). In other embodiments,however, the collar 5112 may first be sealed to the inner surface 5204of the shell 5006, following which the sharp 5012 and the sharp hub 5014may be extended through the aperture 5110, as described above.

The sensor cap 5018 may be removably coupled to the sensor controldevice 5002 by threadably mating the internal threads 5026 b of thesensor cap 5018 with the external threads 5026 a of the mating member5016. Tightening (rotating) the mated engagement between the sensor cap5018 and the mating member 5016 may urge the first end 5020 a of thesensor cap 5018 into sealed engagement with the bottom 5118 of thecollar 5112. Moreover, tightening the mated engagement between thesensor cap 5018 and the mating member 5016 may also enhance the sealedinterface between the sharp hub 5014 and the top of the shell 5006, andbetween the annular ridge 5114 and the inner surface 5204 of the shell5006.

The inner chamber 5022 may be sized and otherwise configured to receivethe tail 5104 and the sharp tip 5108. Moreover, the inner chamber 5022may be sealed to isolate the tail 5104 and the sharp tip 5108 fromsubstances that might adversely interact with the chemistry of the tail5104. In some embodiments, a desiccant 5208 (shown in dashed lines) maybe present within the inner chamber 5022 to maintain proper humiditylevels.

Once properly assembled, the sealed subassembly 5200 may be subjected toany of the radiation sterilization processes mentioned herein toproperly sterilize the sensor 5010 and the sharp 5012. Thissterilization step may be undertaken apart from the remaining portionsof the sensor control device (FIGS. 50A-50B and 51A-51B) to preventdamage to sensitive electrical components. The sealed subassembly 5200may be subjected to radiation sterilization prior to or after couplingthe sensor cap 5018 to the sharp hub 5014. When sterilized aftercoupling the sensor cap 5018 to the sharp hub 5014, the sensor cap 5018may be made of a material that permits the propagation of radiationtherethrough. In some embodiments, the sensor cap 5018 may betransparent or translucent, but can otherwise be opaque, withoutdeparting from the scope of the disclosure.

FIGS. 53A-53C are progressive cross-sectional side views showingassembly of the sensor applicator 102 with the sensor control device5002, according to one or more embodiments. Once the sensor controldevice 5002 is fully assembled, it may then be loaded into the sensorapplicator 102. With reference to FIG. 53A, the sharp hub 5014 mayinclude or otherwise define a hub snap pawl 5302 configured to helpcouple the sensor control device 5002 to the sensor applicator 102. Morespecifically, the sensor control device 5002 may be advanced into theinterior of the sensor applicator 102 and the hub snap pawl 5302 may bereceived by corresponding arms 5304 of a sharp carrier 5306 positionedwithin the sensor applicator 102.

In FIG. 53B, the sensor control device 5002 is shown received by thesharp carrier 5306 and, therefore, secured within the sensor applicator102. Once the sensor control device 5002 is loaded into the sensorapplicator 102, the applicator cap 210 may be coupled to the sensorapplicator 102. In some embodiments, the applicator cap 210 and thehousing 208 may have opposing, matable sets of threads 5308 that enablethe applicator cap 210 to be screwed onto the housing 208 in a clockwise(or counter-clockwise) direction and thereby secure the applicator cap210 to the sensor applicator 102.

As illustrated, the sheath 212 is also positioned within the sensorapplicator 102, and the sensor applicator 102 may include a sheathlocking mechanism 5310 configured to ensure that the sheath 212 does notprematurely collapse during a shock event. In the illustratedembodiment, the sheath locking mechanism 5310 may comprise a threadedengagement between the applicator cap 210 and the sheath 212. Morespecifically, one or more internal threads 5312 a may be defined orotherwise provided on the inner surface of the applicator cap 210, andone or more external threads 5312 b may be defined or otherwise providedon the sheath 212. The internal and external threads 5312 a,b may beconfigured to threadably mate as the applicator cap 210 is threaded tothe sensor applicator 102 at the threads 5308. The internal and externalthreads 5312 a,b may have the same thread pitch as the threads 5308 thatenable the applicator cap 210 to be screwed onto the housing 208.

In FIG. 53C, the applicator cap 210 is shown fully threaded (coupled) tothe housing 208. As illustrated, the applicator cap 210 may furtherprovide and otherwise define a cap post 5314 centrally located withinthe interior of the applicator cap 210 and extending proximally from thebottom thereof. The cap post 5314 may be configured to receive at leasta portion of the sensor cap 5018 as the applicator cap 210 is screwedonto the housing 208.

With the sensor control device 5002 loaded within the sensor applicator102 and the applicator cap 210 properly secured, the sensor controldevice 5002 may then be subjected to a gaseous chemical sterilizationconfigured to sterilize the electronics housing 5004 and any otherexposed portions of the sensor control device 5002. The gaseous chemicalsterilization process may be similar to the gaseous chemicalsterilization 4704 of FIG. 47B and, therefore, will not be describedagain in detail. Since the distal portions of the sensor 5010 and thesharp 5012 are sealed within the sensor cap 5018, the chemicals usedduring the gaseous chemical sterilization process are unable to interactwith the enzymes, chemistry, and biologics provided on the tail 5104,and other sensor components, such as membrane coatings that regulateanalyte influx.

FIGS. 54A and 54B are perspective and top views, respectively, of thecap post 5314, according to one or more additional embodiments. In theillustrated depiction, a portion of the sensor cap 5018 is receivedwithin the cap post 5314 and, more specifically, the desiccant cap 5030of the sensor cap 5018 is arranged within cap post 5314.

As illustrated, the cap post 5314 may define a receiver feature 5402configured to receive the engagement feature 5024 of the sensor cap 5018upon coupling (e.g., threading) the applicator cap 210 (FIG. 53C) to thesensor applicator 102 (FIGS. 53A-53C). Upon removing the applicator cap210 from the sensor applicator 102, however, the receiver feature 5402may prevent the engagement feature 914 from reversing direction and thusprevent the sensor cap 5018 from separating from the cap post 5314.Instead, removing the applicator cap 210 from the sensor applicator 102will simultaneously detach the sensor cap 5018 from the sensor controldevice 5002 (FIGS. 50A-50B and 53A-53C), and thereby expose the distalportions of the sensor 5010 (FIGS. 53A-53C) and the sharp 5012 (FIGS.53A-53C).

Many design variations of the receiver feature 5402 may be employed,without departing from the scope of the disclosure. In the illustratedembodiment, the receiver feature 5402 includes one or more compliantmembers 5404 (two shown) that are expandable or flexible to receive theengagement feature 5024 (FIGS. 50A-50B). The engagement feature 5024 maycomprise, for example, an enlarged head and the compliant member(s) 5404may comprise a collet-type device that includes a plurality of compliantfingers configured to flex radially outward to receive the enlargedhead.

The compliant member(s) 5404 may further provide or otherwise definecorresponding ramped surfaces 5406 configured to interact with one ormore opposing camming surfaces 5408 provided on the outer wall of theengagement feature 5024. The configuration and alignment of the rampedsurface(s) 5406 and the opposing camming surface(s) 5408 is such thatthe applicator cap 210 is able to rotate relative to the sensor cap 5018in a first direction A (e.g., clockwise), but the cap post 5314 bindsagainst the sensor cap 5018 when the applicator cap 210 is rotated in asecond direction B (e.g., counter clockwise). More particularly, as theapplicator cap 210 (and thus the cap post 5314) rotates in the firstdirection A, the camming surfaces 5408 engage the ramped surfaces 5406,which urge the compliant members 5404 to flex or otherwise deflectradially outward and results in a ratcheting effect. Rotating theapplicator cap 210 (and thus the cap post 5314) in the second directionB, however, will drive angled surfaces 5410 of the camming surfaces 5408into opposing angled surfaces 5412 of the ramped surfaces 5406, whichresults in the sensor cap 5018 binding against the compliant member(s)5404.

FIG. 55 is a cross-sectional side view of the sensor control device 5002positioned within the applicator cap 210, according to one or moreembodiments. As illustrated, the opening to the receiver feature 5402exhibits a first diameter D₃, while the engagement feature 5024 of thesensor cap 5018 exhibits a second diameter D₄ that is larger than thefirst diameter D₃ and greater than the outer diameter of the remainingportions of the sensor cap 5018. As the sensor cap 5018 is extended intothe cap post 5314, the compliant member(s) 5404 of the receiver feature5402 may flex (expand) radially outward to receive the engagementfeature 5024. In some embodiments, as illustrated, the engagementfeature 5024 may provide or otherwise define an angled outer surfacethat helps bias the compliant member(s) 5404 radially outward. Once theengagement feature 5024 bypasses the receiver feature 5402, thecompliant member(s) 5404 are able to flex back to (or towards) theirnatural state and thus lock the sensor cap 5018 within the cap post5314.

As the applicator cap 210 is threaded to (screwed onto) the housing 208(FIGS. 53A-53C) in the first direction A, the cap post 5314correspondingly rotates in the same direction and the sensor cap 5018 isprogressively introduced into the cap post 5314. As the cap post 5314rotates, the ramped surfaces 5406 of the compliant members 5404 ratchetagainst the opposing camming surfaces 5408 of the sensor cap 5018. Thiscontinues until the applicator cap 210 is fully threaded onto (screwedonto) the housing 208. In some embodiments, the ratcheting action mayoccur over two full revolutions of the applicator cap 210 before theapplicator cap 210 reaches its final position.

To remove the applicator cap 210, the applicator cap 210 is rotated inthe second direction B, which correspondingly rotates the cap post 5314in the same direction and causes the camming surfaces 5408 (i.e., theangled surfaces 5410 of FIGS. 54A-54B) to bind against the rampedsurfaces 5406 (i.e., the angled surfaces 5412 of FIGS. 54A-54B).Consequently, continued rotation of the applicator cap 210 in the seconddirection B causes the sensor cap 5018 to correspondingly rotate in thesame direction and thereby unthread from the mating member 5016 to allowthe sensor cap 5018 to detach from the sensor control device 5002.Detaching the sensor cap 5018 from the sensor control device 5002exposes the distal portions of the sensor 5010 and the sharp 5012, andthus places the sensor control device 5002 in position for firing (use).

FIGS. 56A and 56B are cross-sectional side views of the sensorapplicator 102 ready to deploy the sensor control device 5002 to atarget monitoring location, according to one or more embodiments. Morespecifically, FIG. 56A depicts the sensor applicator 102 ready to deploy(fire) the sensor control device 5002, and FIG. 56B depicts the sensorapplicator 102 in the process of deploying (firing) the sensor controldevice 5002. As illustrated, the applicator cap 210 (FIGS. 53A-53C and55) has been removed, which correspondingly detaches (removes) thesensor cap 5018 (FIGS. 53A-53C and 55 and thereby exposes the tail 5104of the sensor 5010 and the sharp tip 5108 of the sharp 5012, asdescribed above. In conjunction with the sheath 212 and the sharpcarrier 5306, the sensor applicator 102 also includes a sensor carrier5602 (alternately referred to as a “puck” carrier) that helps positionand secure the sensor control device 5002 within the sensor applicator102.

Referring first to FIG. 56A, as illustrated, the sheath 212 includes oneor more sheath arms 5604 (one shown) configured to interact with acorresponding one or more detents 5606 (one shown) defined within theinterior of the housing 208. The detent(s) 5606 are alternately referredto as “firing” detent(s). When the sensor control device 5002 isinitially installed in the sensor applicator 102, the sheath arms 5604may be received within the detents 5606, which places the sensorapplicator 102 in firing position. In the firing position, the matingmember 5016 extends distally beyond the bottom of the sensor controldevice 5002. As discussed below, the process of firing the sensorapplicator 102 causes the mating member 5016 to retract so that it doesnot contact the user's skin.

The sensor carrier 5602 may also include one or more carrier arms 5608(one shown) configured to interact with a corresponding one or moregrooves 5610 (one shown) defined on the sharp carrier 5306. A spring5612 may be arranged within a cavity defined by the sharp carrier 5306and may passively bias the sharp carrier 5306 upward within the housing208. When the carrier arm(s) 5608 are properly received within thegroove(s) 5610, however, the sharp carrier 5306 is maintained inposition and prevented from moving upward. The carrier arm(s) 5608interpose the sheath 212 and the sharp carrier 5306, and a radialshoulder 5614 defined on the sheath 212 may be sized to maintain thecarrier arm(s) 5608 engaged within the groove(s) 5610 and therebymaintain the sharp carrier 5306 in position.

In FIG. 56B, the sensor applicator 102 is in the process of firing. Asdiscussed herein with reference to FIGS. 2F-2G, this may be accomplishedby advancing the sensor applicator 102 toward a target monitoringlocation until the sheath 212 engages the skin of the user. Continuedpressure on the sensor applicator 102 against the skin may cause thesheath arm(s) 5604 to disengage from the corresponding detent(s) 5606,which allows the sheath 212 to collapse into the housing 208. As thesheath 212 starts to collapse, the radial shoulder 5614 eventually movesout of radial engagement with the carrier arm(s) 5608, which allows thecarrier arm(s) 5608 to disengage from the groove(s) 5610. The passivespring force of the spring 5612 is then free to push upward on the sharpcarrier 5306 and thereby force the carrier arm(s) 5608 out of engagementwith the groove(s) 5610, which allows the sharp carrier 5306 to moveslightly upward within the housing 208. In some embodiments, fewer coilsmay be incorporated into the design of the spring 5612 to increase thespring force necessary to overcome the engagement between carrier arm(s)5608 and the groove(s) 5610. In at least one embodiment, one or both ofthe carrier arm(s) 5608 and the groove(s) 5610 may be angled to helpease disengagement.

As the sharp carrier 5306 moves upward within the housing 208, the sharphub 5014 may correspondingly move in the same direction, which may causepartial retraction of the mating member 5016 such that it becomes flush,substantially flush, or sub-flush with the bottom of the sensor controldevice 5002. As will be appreciated, this ensures that the mating member5016 does not come into contact with the user's skin, which mightotherwise adversely impact sensor insertion, cause excessive pain, orprevent the adhesive patch (not shown) positioned on the bottom of thesensor control device 5002 from properly adhering to the skin.

FIGS. 57A-57C are progressive cross-sectional side views showingassembly and disassembly of an alternative embodiment of the sensorapplicator 102 with the sensor control device 5002, according to one ormore additional embodiments. A fully assembled sensor control device5002 may be loaded into the sensor applicator 102 by coupling the hubsnap pawl 5302 into the arms 5304 of the sharp carrier 5306 positionedwithin the sensor applicator 102, as generally described above.

In the illustrated embodiment, the sheath arms 5604 of the sheath 212may be configured to interact with a first detent 5702 a and a seconddetent 5702 b defined within the interior of the housing 208. The firstdetent 5702 a may alternately be referred to a “locking” detent, and thesecond detent 5702 b may alternately be referred to as a “firing”detent. When the sensor control device 5002 is initially installed inthe sensor applicator 102, the sheath arms 5604 may be received withinthe first detent 5702 a. As discussed below, the sheath 212 may beactuated to move the sheath arms 5604 to the second detent 5702 b, whichplaces the sensor applicator 102 in firing position.

In FIG. 57B, the applicator cap 210 is aligned with the housing 208 andadvanced toward the housing 208 so that the sheath 212 is receivedwithin the applicator cap 210. Instead of rotating the applicator cap210 relative to the housing 208, the threads of the applicator cap 210may be snapped onto the corresponding threads of the housing 208 tocouple the applicator cap 210 to the housing 208. Axial cuts or slots5703 (one shown) defined in the applicator cap 210 may allow portions ofthe applicator cap 210 near its threading to flex outward to be snappedinto engagement with the threading of the housing 208. As the applicatorcap 210 is snapped to the housing 208, the sensor cap 5018 maycorrespondingly be snapped into the cap post 5314.

Similar to the embodiment of FIGS. 53A-53C, the sensor applicator 102may include a sheath locking mechanism configured to ensure that thesheath 212 does not prematurely collapse during a shock event. In theillustrated embodiment, the sheath locking mechanism includes one ormore ribs 5704 (one shown) defined near the base of the sheath 212 andconfigured to interact with one or more ribs 5706 (two shown) and ashoulder 5708 defined near the base of the applicator cap 210. The ribs5704 may be configured to inter-lock between the ribs 5706 and theshoulder 5708 while attaching the applicator cap 210 to the housing 208.More specifically, once the applicator cap 210 is snapped onto thehousing 208, the applicator cap 210 may be rotated (e.g., clockwise),which locates the ribs 5704 of the sheath 212 between the ribs 5706 andthe shoulder 5708 of the applicator cap 210 and thereby “locks” theapplicator cap 210 in place until the user reverse rotates theapplicator cap 210 to remove the applicator cap 210 for use. Engagementof the ribs 5704 between the ribs 5706 and the shoulder 5708 of theapplicator cap 210 may also prevent the sheath 212 from collapsingprematurely.

In FIG. 57C, the applicator cap 210 is removed from the housing 208. Aswith the embodiment of FIGS. 53A-53C, the applicator cap 210 can beremoved by reverse rotating the applicator cap 210, whichcorrespondingly rotates the cap post 5314 in the same direction andcauses sensor cap 5018 to unthread from the mating member 5016, asgenerally described above. Moreover, detaching the sensor cap 5018 fromthe sensor control device 5002 exposes the distal portions of the sensor5010 and the sharp 5012.

As the applicator cap 210 is unscrewed from the housing 208, the ribs5704 defined on the sheath 212 may slidingly engage the tops of the ribs5706 defined on the applicator cap 210. The tops of the ribs 5706 mayprovide corresponding ramped surfaces that result in an upwarddisplacement of the sheath 212 as the applicator cap 210 is rotated, andmoving the sheath 212 upward causes the sheath arms 5604 to flex out ofengagement with the first detent 5702 a to be received within the seconddetent 5702 b. As the sheath 212 moves to the second detent 5702 b, theradial shoulder 5614 moves out of radial engagement with the carrierarm(s) 5608, which allows the passive spring force of the spring 5612 topush upward on the sharp carrier 5306 and force the carrier arm(s) 5608out of engagement with the groove(s) 5610. As the sharp carrier 5306moves upward within the housing 208, the mating member 5016 maycorrespondingly retract until it becomes flush, substantially flush, orsub-flush with the bottom of the sensor control device 5002. At thispoint, the sensor applicator 102 in firing position. Accordingly, inthis embodiment, removing the applicator cap 210 correspondingly causesthe mating member 5016 to retract.

FIG. 58A is an isometric bottom view of the housing 208, according toone or more embodiments. As illustrated, one or more longitudinal ribs5802 (four shown) may be defined within the interior of the housing 208.The ribs 5802 may be equidistantly or non-equidistantly spaced from eachother and extend substantially parallel to centerline of the housing208. The first and second detents 5702 a,b may be defined on one or moreof the longitudinal ribs 5802.

FIG. 58B is an isometric bottom view of the housing 208 with the sheath212 and other components at least partially positioned within thehousing 208. As illustrated, the sheath 212 may provide or otherwisedefine one or more longitudinal slots 5804 configured to mate with thelongitudinal ribs 5802 of the housing 208. As the sheath 212 collapsesinto the housing 208, as generally described above, the ribs 5802 may bereceived within the slots 5804 to help maintain the sheath 212 alignedwith the housing during its movement. As will be appreciated, this mayresult in tighter circumferential and radial alignment within the samedimensional and tolerance restrictions of the housing 208.

In the illustrated embodiment, the sensor carrier 5602 may be configuredto hold the sensor control device 5002 in place both axially (e.g., oncethe sensor cap 5018 is removed) and circumferentially. To accomplishthis, the sensor carrier 5602 may include or otherwise define one ormore support ribs 5806 and one or more flexible arms 5808. The supportribs 5806 extend radially inward to provide radial support to the sensorcontrol device 5002. The flexible arms 5808 extend partially about thecircumference of the sensor control device 5002 and the ends of theflexible arms 5808 may be received within corresponding grooves 5810defined in the side of the sensor control device 5002. Accordingly, theflexible arms 5808 may be able to provide both axial and radial supportto the sensor control device 5002. In at least one embodiment, the endsof the flexible arms 5808 may be biased into the grooves 5810 of thesensor control device 5002 and otherwise locked in place withcorresponding sheath locking ribs 5812 provided by the sheath 212.

In some embodiments, the sensor carrier 5602 may be ultrasonicallywelded to the housing 208 at one or more points 5814. In otherembodiments, however, the sensor carrier 5602 may alternatively becoupled to the housing 208 via a snap-fit engagement, without departingfrom the scope of the disclosure. This may help hold the sensor controldevice 5002 in place during transport and firing.

FIG. 59 is an enlarged cross-sectional side view of the sensorapplicator 102 with the sensor control device 5002 installed therein,according to one or more embodiments. As discussed above, the sensorcarrier 5602 may include one or more carrier arms 5608 (two shown)engageable with the sharp carrier 5306 at corresponding grooves 5610. Inat least one embodiment, the grooves 5610 may be defined by pairs ofprotrusions 5902 defined on the sharp carrier 5306. Receiving thecarrier arms 5608 within the grooves 5610 may help stabilize the sharpcarrier 5306 from unwanted tilting during all stages of retraction(firing).

In the illustrated embodiment, the arms 5304 of the sharp carrier 5306may be stiff enough to control, with greater refinement, radial andbi-axial motion of the sharp hub 5014. In some embodiments, for example,clearances between the sharp hub 5014 and the arms 5304 may be morerestrictive in both axial directions as the relative control of theheight of the sharp hub 5014 may be more critical to the design.

In the illustrated embodiment, the sensor carrier 5602 defines orotherwise provides a central boss 5904 sized to receive the sharp hub5014. In some embodiments, as illustrated, the sharp hub 5014 mayprovide one or more radial ribs 5906 (two shown). In at least oneembodiment, the inner diameter of the central boss 5904 helps provideradial and tilt support to the sharp hub 5014 during the life of sensorapplicator 102 and through all phases of operation and assembly.Moreover, having multiple radial ribs 5906 increases the length-to-widthratio of the sharp hub 5014, which also improves support againsttilting.

FIG. 60A is an isometric top view of the applicator cap 210, accordingto one or more embodiments. In the illustrated embodiment, two axialslots 5703 are depicted that separate upper portions of the applicatorcap 210 near its threading. As mentioned above, the slots 5703 may helpthe applicator cap 210 flex outward to be snapped into engagement withthe housing 208 (FIG. 57B). In contrast, the applicator cap 210 may betwisted (unthreaded) off the housing 208 by an end user.

FIG. 60A also depicts the ribs 5706 (one visible) defined by theapplicator cap 210. By interlocking with the ribs 5704 (FIG. 57C)defined on the sheath 212 (FIG. 57C), the ribs 5706 may help lock thesheath 212 in all directions to prevent premature collapse during ashock or drop event. The sheath 212 may be unlocked when the userunscrews the applicator cap 210 from the housing (FIG. 59C), asgenerally described above. As mentioned herein, the top of each rib 5706may provide a corresponding ramped surface 6002, and as the applicatorcap 210 is rotated to unthread from the housing 208, the ribs 5704defined on the sheath 212 may slidingly engage the ramped surfaces 6002,which results in the upward displacement of the sheath 212 into thehousing 208.

In some embodiments, additional features may be provided within theinterior of the applicator cap 210 to hold a desiccant component thatmaintains proper moisture levels through shelf life. Such additionalfeatures may be snaps, posts for press-fitting, heat-staking, ultrasonicwelding, etc.

FIG. 60B is an enlarged cross-sectional view of the engagement betweenthe applicator cap 210 and the housing 208, according to one or moreembodiments. As illustrated, the applicator cap 210 may define a set ofinner threads 6004 and the housing 208 may define a set of outer threads6006 engageable with the inner threads 6004. As mentioned herein, theapplicator cap 210 may be snapped onto the housing 208, which may beaccomplished by advancing the inner threads 6004 axially past the outerthreads 6006 in the direction indicated by the arrow, which causes theapplicator cap 210 to flex outward. To help ease this transition, asillustrated, corresponding surfaces 6008 of the inner and outer threads6004, 6006 may be curved, angled, or chamfered. Corresponding flatsurfaces 6010 may be provided on each thread 6004, 6006 and configuredto matingly engage once the applicator cap 210 is properly snapped intoplace on the housing 208. The flat surfaces 6010 may slidingly engageone another as the user unthreads the applicator cap 210 from thehousing 208.

The threaded engagement between the applicator cap 210 and the housing208 results in a sealed engagement that protects the inner componentsagainst moisture, dust, etc. In some embodiments, the housing 208 maydefine or otherwise provide a stabilizing feature 6012 configured to bereceived within a corresponding groove 1914 defined on the applicatorcap 210. The stabilizing feature 6012 may help stabilize and stiffen theapplicator cap 210 once the applicator cap 210 is snapped onto thehousing 208. This may prove advantageous in providing additional droprobustness to the sensor applicator 102. This may also help increase theremoval torque of the applicator cap 210.

FIGS. 61A and 61B are isometric views of the sensor cap 5018 and thecollar 5112, respectively, according to one or more embodiments.Referring to FIG. 61A, in some embodiments, the sensor cap 5018 maycomprise an injection molded part. This may prove advantageous inmolding the internal threads 5026 a defined within the inner chamber5022, as opposed to installing a threaded core or threading the innerchamber 5022. In some embodiments, one or more stop ribs 6102 (onvisible) may be defined within the inner chamber 5022 to prevent overtravel relative to mating member 5016 of the sharp hub 5014 (FIGS.50A-50B).

Referring to both FIGS. 61A and 61B, in some embodiments, one or moreprotrusions 6104 (two shown) may be defined on the first end 5020 a ofthe sensor cap 5018 and configured to mate with one or morecorresponding indentations 6106 (two shown) defined on the collar 5112.In other embodiments, however, the protrusions 6104 may instead bedefined on the collar 5112 and the indentations 6106 may be defined onthe sensor cap 5018, without departing from the scope of the disclosure.

The matable protrusions 6104 and indentations 6106 may proveadvantageous in rotationally locking the sensor cap 5018 to preventunintended unscrewing of the sensor cap 5018 from the collar 5112 (andthus the sensor control device 5002) during the life of the sensorapplicator 102 and through all phases of operation/assembly. In someembodiments, as illustrated, the indentations 6106 may be formed orotherwise defined in the general shape of a kidney bean. This may proveadvantageous in allowing for some over-rotation of the sensor cap 5018relative to the collar 5112. Alternatively, the same benefit may beachieved via a flat end threaded engagement between the two parts.

Embodiments disclosed herein include:

U. A sensor control device that includes an electronics housing, asensor arranged within the electronics housing and having a tailextending from a bottom of the electronics housing, a sharp extendingthrough the electronics housing and having a sharp tip extending fromthe bottom of the electronics housing, and a sensor cap removablycoupled at the bottom of the electronics housing and defining a sealedinner chamber that receives the tail and the sharp.

V. An analyte monitoring system that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing, a sensor arranged within theelectronics housing and having a tail extending from a bottom of theelectronics housing, a sharp extending through the electronics housingand having a sharp tip extending from the bottom of the electronicshousing, and a sensor cap removably coupled at the bottom of theelectronics housing and defining an engagement feature and a sealedinner chamber that receives the tail and the sharp. The analytemonitoring system may further include a cap coupled to the sensorapplicator and providing a cap post defining a receiver feature thatreceives the engagement feature upon coupling the cap to the sensorapplicator, wherein removing the cap from the sensor applicator detachesthe sensor cap from the electronics housing and thereby exposes the tailand the sharp tip.

W. A method of preparing an analyte monitoring system that includesloading a sensor control device into a sensor applicator, the sensorcontrol device including an electronics housing, a sensor arrangedwithin the electronics housing and having a tail extending from a bottomof the electronics housing, a sharp extending through the electronicshousing and having a sharp tip extending from the bottom of theelectronics housing, and a sensor cap removably coupled at the bottom ofthe electronics housing and defining a sealed inner chamber thatreceives the tail and the sharp. The method further including securing acap to the sensor applicator, sterilizing the sensor control device withgaseous chemical sterilization while the sensor control device ispositioned within the sensor applicator, and isolating the tail and thesharp tip within the inner chamber from the gaseous chemicalsterilization.

Each of embodiments U, V, and W may have one or more of the followingadditional elements in any combination: Element 1: wherein the sensorcap comprises a cylindrical body having a first end that is open toaccess the inner chamber, and a second end opposite the first end andproviding an engagement feature engageable with a cap of a sensorapplicator, wherein removing the cap from the sensor applicatorcorrespondingly removes the sensor cap from the electronics housing andthereby exposes the tail and the sharp tip. Element 2: wherein theelectronics housing includes a shell matable with a mount, the sensorcontrol device further comprising a sharp and sensor locator defined onan inner surface of the shell, and a collar received about the sharp andsensor locator, wherein the sensor cap is removably coupled to thecollar. Element 3: wherein the sensor cap is removably coupled to thecollar by one or more of an interference fit, a threaded engagement, afrangible member, and a frangible substance. Element 4: wherein anannular ridge circumscribes the sharp and sensor locator and the collarprovides a column and an annular shoulder extending radially outwardfrom the column, and wherein a seal member interposes the annularshoulder and the annular ridge to form a sealed interface. Element 5:wherein the annular ridge defines a groove and a portion of the sensoris seated within the groove, and wherein the seal member extends intothe groove to seal about the portion of the sensor. Element 6: whereinthe seal member is a first seal member, the sensor control devicefurther comprising a second seal member interposing the annular shoulderand a portion of the mount to form a sealed interface. Element 7:wherein the electronics housing includes a shell matable with a mount,the sensor control device further comprising a sharp hub that carriesthe sharp and is engageable with a top surface of the shell, and amating member defined by the sharp hub and extending from the bottom ofthe electronics housing, wherein the sensor cap is removably coupled tothe mating member. Element 8: further comprising a collar at leastpartially receivable within an aperture defined in the mount andsealingly engaging the sensor cap and an inner surface of the shell.Element 9: wherein a seal member interposes the collar and the innersurface of the shell to form a sealed interface. Element 10: wherein thecollar defines a groove and a portion of the sensor is seated within thegroove, and wherein the seal member extends into the groove to sealabout the portion of the sensor.

Element 11: wherein the receiver feature comprises one or more compliantmembers that flex to receive the engagement feature, and wherein the oneor more compliant members prevent the engagement feature from exitingthe cap post upon removing the cap from the sensor applicator. Element12: further comprising a ramped surface defined on at least one of theone or more compliant members, and one or more camming surfaces providedby the engagement feature and engageable with the ramped surface,wherein the ramped surface and the one or more camming surfaces allowthe cap and the cap post to rotate relative to the sensor cap in a firstdirection, but prevent the cap and the cap post from rotating relativeto the sensor cap in a second direction opposite the first direction.Element 13: wherein the electronics housing includes a shell matablewith a mount, the sensor control device further comprising a sharp hubthat carries the sharp and is engageable with a top surface of theshell, and a mating member defined by the sharp hub and extending fromthe bottom of the electronics housing, wherein the sensor cap isremovably coupled to the mating member and rotating the cap in thesecond direction detaches the sensor cap from the mating member. Element14: wherein the electronics housing includes a shell matable with amount and the sensor control device further includes a sharp and sensorlocator defined on an inner surface of the shell, and a collar receivedabout the sharp and sensor locator, wherein the sensor cap is removablycoupled to the collar.

Element 15: wherein the cap provides a cap post defining a receiverfeature and the sensor cap defines an engagement feature, the methodfurther comprising receiving the engagement feature with the receiverfeature as the cap is secured to the sensor applicator. Element 16:further comprising removing the cap from the sensor applicator, andengaging the engagement feature on the receiver feature as the cap isbeing removed and thereby detaching the sensor cap from the electronicshousing and exposing the tail and the sharp tip. Element 17: whereinloading the sensor control device into a sensor applicator is precededby sterilizing the tail and the sharp tip with radiation sterilization,and sealing the tail and the sharp tip within the inner chamber.

By way of non-limiting example, exemplary combinations applicable to U,V, and W include: Element 2 with Element 3; Element 2 with Element 4;Element 4 with Element 5; Element 4 with Element 6; Element 7 withElement 8; Element 8 with Element 9; Element 9 with Element 10; Element11 with Element 12; and Element 15 with Element 16.

Sensor Applicator with Actuating Needle Shroud

Referring again briefly to FIG. 1, the sensor control device 104 isoften included with the sensor applicator 104 in what is known as a“two-piece” architecture that requires final assembly by a user beforethe sensor 110 can be properly delivered to the target monitoringlocation. In such applications, the sensor 110 and the associatedelectrical components included in the sensor control device 104 areprovided to the user in multiple (two) packages, and the user must openthe packaging and follow instructions to manually assemble thecomponents before delivering the sensor 110 to the target monitoringlocation with the sensor applicator 6302. More recently, however,advanced designs of sensor control devices and associated sensorapplicators have resulted in a one-piece architecture that allows thesystem to be shipped to the user in a single, sealed package that doesnot require any final user assembly steps. Rather, the user need onlyopen one package, remove an applicator cap, and subsequently deliver thesensor control device to the target monitoring location.

Notwithstanding these advances, conventional sensor applicators commonlyinclude a shroud that surrounds the entire outer periphery of the sensorcontrol device. To deploy the sensor control device, the shroud isforced against the skin and retracts into the sensor applicator, whichcauses the combination introducer and sensor to be deliveredtranscutaneously under the user's skin. Having the shroud positionedaway from the insertion site near the introducer leaves the skin at theinsertion site in a generally soft and uncompressed state. It can bedifficult to insert a sensor in uncompressed soft tissue due to the skindepression that occurs as the introducer tip enters the skin, commonlyreferred to as skin “tenting”. Embodiments of the present disclosureinclude sensor applicators that incorporate a needle shroud to applypressure to the skin at or near the insertion site.

FIG. 62 is an isometric top view of an example sensor control device6202, according to one or more embodiments of the present disclosure.The sensor control device 6202 may be the same as or similar to thesensor control device 104 of FIG. 1 and, therefore, may be designed tobe delivered to a target monitoring location on a user's skin throughoperation of a sensor applicator (not shown). As illustrated, the sensorcontrol device 6202 includes an electronics housing 6204 that isgenerally disc-shaped and may have a circular cross-section. In otherembodiments, however, the electronics housing 6204 may exhibit othercross-sectional shapes, such as oval, ovoid (e.g., pill- or egg-shaped),a squircle, polygonal, or any combination thereof, without departingfrom the scope of the disclosure. The electronics housing 6204 may houseor otherwise contain various electronic components used to operate thesensor control device 6202. For example, a printed circuit board (PCB)may be positioned within the electronics housing and may have theretoone or more of a battery, a data processing unit, and various resistors,transistors, capacitors, inductors, diodes, and switches.

The electronics housing 6204 may include a shell 6206 and a mount 6208that is matable with the shell 6206. The shell 6206 may be secured tothe mount 6208 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, one or more mechanical fasteners (e.g.,screws), or any combination thereof. In some cases, the shell 6206 maybe secured to the mount 6208 such that a sealed interface is generatedtherebetween. In such embodiments, a gasket or other type of sealmaterial may be positioned at or near the outer diameter (periphery) ofthe shell 6206 and the mount 6208, and securing the two componentstogether may compress the gasket and thereby generate a sealedinterface. In other embodiments, an adhesive may be applied to the outerdiameter (periphery) of one or both of the shell 6206 and the mount6208. The adhesive secures the shell 6206 to the mount 6208 and providesstructural integrity, but may also seal the interface between the twocomponents and thereby isolate the interior of the electronics housing6204 from outside contamination.

In the illustrated embodiment, the sensor control device 6202 alsoincludes a sensor module 6210 interconnectable with a sharp module 6212.The sensor module 6210 may be coupled to the electronics housing 6204with a collar 6214, and the collar 6214 may be mounted to theelectronics housing 6204 within an aperture 6215 defined therethrough.The sensor module 6210 may include a sensor 6216 and a flexibleconnector 6218 used to help connect the sensor 6216 to the electroniccomponents housed within the electronics housing 6204. A tail 6220 ofthe sensor 6216 may extend distally from the electronics housing 6204and, more particularly, from the bottom of the mount 6208.

The sharp module 6212 may carry or otherwise include an introducer orsharp 6222 used to help deliver the sensor 6216 transcutaneously under auser's skin during deployment of the sensor control device 6202. In theillustrated embodiment, the sharp module 6212 includes a sharp hub 6224that carries the sharp 6222. In one embodiment, the sharp hub 6224 maybe overmolded onto the sharp 6222, but could alternatively be fabricatedfrom plastic, metal, or another suitable material as a separatecomponent, and bonded, welded, or mechanically attached to the sharp6222. Similar to the tail 6220, the distal end of the sharp 6222 mayextend distally from the electronics housing 6204 and, moreparticularly, from the bottom of the mount 6208. In at least oneembodiment, the tail 6220 may be received within a hollow or recessedportion of the sharp 6222.

While the sensor control device 6202 is depicted as an eccentricassembly, with the sensor 6216 and the sharp 6222 extending distally ata location offset from a central axis of the electronics housing 6204,embodiments are contemplated herein where the sensor 6216 and the sharp6222 are aligned with the central axis in a concentric design, withoutdeparting from the scope of the disclosure. Moreover, an adhesive patch6226 may be positioned on and otherwise attached to the underside of themount 6208. Similar to the adhesive patch 108 of FIG. 1, the adhesivepatch 6226 may be configured to secure and maintain the sensor controldevice 6202 in position on the user's skin during operation.

FIG. 63 is a schematic side view of an example sensor applicator 6302,according to one or more embodiments of the present disclosure. Thesensor applicator 6302 may be similar in some respects to the sensorapplicator 102 of FIG. 1 and, therefore, may be configured to house andfacilitate deployment of a sensor control device, such as the sensorcontrol device 6202 (shown in dashed lines). As illustrated, the sensorapplicator 6302 may include a housing 6304 sized to receive the sensorcontrol device 6202 therein. In some embodiments, an applicator cap 6306may be removably coupled to the housing 6304. The applicator cap 6306may be threaded to the housing 6304, for example, but couldalternatively be coupled thereto via a snap fit engagement, aninterference fit, or the like, without departing from the scope of thedisclosure. The applicator cap 6306 may help protect and shield theadhesive patch 6226 from contaminants or damage prior to deploying thesensor control device 6202.

The sensor applicator 6302 may also include a sensor cap 6308 extendingfrom the bottom of the sensor applicator 6302. The sensor cap 6308 maybe configured to receive and protect the distal ends of the sensor 6216and the sharp 6222 extending from the bottom of the electronics housing6204. In some embodiments, the sensor cap 6308 may be coupled to orotherwise form an integral part or extension of the applicator cap 6306.In other embodiments, however, the applicator and sensor caps 6306, 6308may constitute separate component parts that may be jointly orseparately removable from the bottom of the housing 6304.

In some embodiments, the sensor cap 6308 may extend from the sensorcontrol device 6202 and form part of a sterile barrier with the collar6214 (FIG. 62) to protect the distal ends of the sensor 6216 and thesharp 6222. In such embodiments, the sensor cap 6308 may be removablycoupled to the collar 6214, such as being threaded to the collar 6214 orcoupled thereto using a bayonet coupling, an interference fit, a snapfit engagement, or any combination thereof. In other embodiments,however, the sensor cap 6308 may alternatively be removably coupled toanother internal feature of the sensor applicator 6302, withoutdeparting from the scope of the disclosure.

In one or more embodiments, the sensor cap 6308 may include a grippinginterface 6310 that provides a location for a user to grasp onto andremove the sensor cap 6308 from the sensor applicator 6302. The grippinginterface 6310 may comprise, for example, a tab that can be grasped bythe user with the thumb and forefinger. Once the applicator cap 6306 andthe sensor cap 6308 are removed, a user may then use the sensorapplicator 6302 to position the sensor control device 6202 (FIG. 62) ata target monitoring location on the user's body, as will be describedbelow.

FIGS. 64A and 64B are exploded isometric views of the sensor applicator6302 and the sensor control device 6202. The applicator cap 6306 and thesensor cap 6308 of FIG. 63 are not shown for simplicity. As illustrated,the collar 6214, the sensor 6216, and the flexible connector 6218(collectively the sensor module 6210 of FIG. 62) may each be mounted tothe electronics housing 6204 at or within the aperture 6215 defined inthe electronics housing 6204.

The sensor applicator 6302 may include a desiccant 6404, a sensorretainer 6406, a needle shroud 6408, and a driver spring 6410. Thedesiccant 6404 may optionally contained within the housing 6304 to helpmaintain appropriate humidity levels. The housing 6304 may be matablewith the sensor retainer 6406 (alternately referred to as a “puckretainer”) to retain the needle shroud 6408, the driver spring 6410, thesharp hub 6224, and the sharp 6222 within the housing 6304. The sensorretainer 6406, the needle shroud 6408, the sharp hub 6224 with the sharp6222, and the driver spring 6410 may all be operatively coupled to helpfacilitate deployment of the sensor control device 6202.

As described below, the needle shroud 6408 may be movable (actuatable)between an extended position and a retracted position to deploy thesensor control device 6202 from the sensor applicator 6302. As best seenin FIG. 64B, the sensor retainer 6406 may have one or more locking tabs6412 engageable with a corresponding one or more locking members 6414provided on the needle shroud 6408. Coupling the locking members 6414 tothe locking tabs 6412 helps secure the needle shroud 6408 in theextended position, whereas disengaging the locking members 6414 from thelocking tabs 6412 allows the needle shroud 6408 to move to the retractedposition.

Those skilled in the art will readily appreciate that the locking tabsand members 6412, 6414 are merely one way to temporarily secure theneedle shroud 6408 in the extended position. In other embodiments, forexample, the locking tabs and members 6412, 6414 may be replaced withcorresponding detents and mating grooves or other common types ofremovable or releasable couplings, without departing from the scope ofthe disclosure.

The sensor retainer 6406 may further include a plurality of upwardlyextending fingers 6414 (three shown) configured to extend partially intothe needle shroud 6408 to help retain the sharp hub 6224 until theneedle shroud 6408 moves to the retracted position. Once the needleshroud 6408 reaches the retracted position, the fingers 6414 may be ableto flex radially outward to release the needle shroud 6408, and thespring force of the driver spring 6410 may retract the sharp 6222 intothe housing 6304.

The sensor retainer 6406 may define an aperture 6418 through which thelower portion of the needle shroud 6408 can extend. The lower end of theneedle shroud 6408 extends through the aperture 6418 (and the aperture6215 provided in the electronics housing 6204) when the needle shroud6408 is in the extended position. Moving the needle shroud 6408 to theretracted position draws the lower end of the needle shroud 6408 upwardthrough the aperture 6418 (and the aperture 6215 of the electronicshousing 6204).

FIGS. 65A-65D are progressive cross-sectional side views of the sensorapplicator 6302 depicting example deployment of the sensor controldevice 6202, according to one or more embodiments. User operation(actuation) of the sensor applicator 6302 can cause the needle shroud6408 to move from the extended position, as shown in FIGS. 65A and 65B,to the retracted position, as shown in FIG. 65D. Once the needle shroud6408 reaches the retracted position, the sensor control device 6202 maybe able to be released (discharged) from the sensor retainer 6406, asdescribed below.

Referring first to FIG. 65A, the applicator cap 6306 is removablycoupled to the housing 6304. In some embodiments, the interface betweenthe applicator cap 6306 and the housing 6304 may be sealed to helpprotect and shield the adhesive patch 6226 from contamination or damageprior to deploying the sensor control device 6202. The sensor cap 6308is also depicted extending distally from the bottom of the sensorapplicator 6302 and, more particularly, from the sensor control device6202.

The sensor cap 6308 may define an interior 6502 sized to receive a lowerportion of the needle shroud 6408 in the extended position. Moreover,distal ends of the sensor 6216 and the sharp 6222 may also extend intothe interior 6502 of the sensor cap 6308 and the needle shroud 6408 maygenerally cover the distal ends of the sensor 6216 and the sharp 6222when the needle shroud 6408 is in the extended position. In someembodiments, a seal 6504 may be positioned at an interface between thetop of the sensor cap 6308 and the collar 6214 and thereby help form asterile barrier for the sensor 6216 and the sharp 6222. In oneembodiment, the seal 6504 may be co-molded or otherwise attached to thetop of the sensor cap 6308. In other embodiments, however, the seal 6504may be co-molded or attached to the collar 6214. In yet otherembodiments, the seal 6504 may be a separate component part, such as anO-ring or the like placed between the top of the sensor cap 6308 and thecollar 6214.

In one embodiment, as mentioned above, the sensor cap 6308 may beremovably coupled to the collar 6214, such as through a bayonetcoupling, an interference fit, a snap fit engagement, or any combinationthereof. In other embodiments, however, the sensor cap 6308 may beremovably coupled to the needle shroud 6408, without departing from thescope of the disclosure. Removably coupling the sensor cap 6308 toeither the collar 6214 or the needle shroud 6408 may help maintaincompression of the seal 6504. To remove the sensor cap 6308 from thesensor applicator 6302, a user may be able to grasp the grippinginterface 6310 on the sensor cap 6308. As indicated above, in someembodiments, both the applicator and sensor caps 6306, 6308 may beremoved simultaneously or separately.

In FIG. 65B, the applicator cap 6306 and the sensor cap 6308 have beenremoved from the sensor applicator 6302, thereby exposing the needleshroud 6408 and the bottom of the sensor control device 6202. With theneedle shroud 6408 in the extended position, as illustrated, the upperportion of the needle shroud 6408 resides within the housing 6304, whilethe lower portion extends distally through the aperture 6418 defined inthe sensor retainer 6406 and through the aperture 6215 defined throughthe sensor control device 6202. The upwardly extending fingers 6414 ofthe sensor retainer 6406 may extend into or otherwise be positionedwithin an inner chamber 6506 defined by the upper portion of the needleshroud 6408. Moreover, the sharp hub 6224 may be arranged within orbetween the fingers 6414, and the driver spring 6410 may be arranged tointerpose and engage the sharp hub 6224 and the sensor retainer 6406.

More specifically, the top end of the driver spring 6410 may be receivedwithin a channel 6508 defined by the sharp hub 6224, and the bottom endof the driver spring 6410 may engage one or more projections 6510defined by the sensor retainer 6406 and extending radially into theaperture 6418. Alternatively, the top end of the driver spring 6414 mayengage an upper end of the sharp 6222, thus eliminating the need for anovermolded sharp hub 6224. The driver spring 6410 may be compressedbetween the sharp hub 6224 and the sensor retainer 6406 and preventedfrom releasing its spring force and expanding as long as the fingers6414 are located within the inner chamber 6506. More particularly, thetop of one or more of the fingers 6414 may extend radially inward andover the sharp hub 6224, thus preventing the sharp hub 6224 from movingupward until the fingers 6414 are no longer radially constrained by theinner chamber 6506. Moving the needle shroud 6408 to the retractedposition, however, correspondingly places the fingers 6414 outside ofthe inner chamber 6506, which allows the driver spring 6410 force thesharp hub 6224 past the top of the fingers 6414, as described below.

With the needle shroud 6408 in the extended position, the locking tabs6412 (FIG. 64B) of the sensor retainer 6406 may be engaged with thelocking members 6414 (FIGS. 64A-64B) provided on the needle shroud 6408,which helps secure the needle shroud 6408 in the extended position. Thelocking members 6414 must be disengaged from the locking tabs 6412 toallow the needle shroud 6408 to move to the retracted position andthereby deploy the sensor control device 6202. This can be accomplishedby the user positioning the sensor applicator 6302 at the targetmonitoring location and forcing the needle shroud 6408 against the skin,which places an axial load on the bottom end of the needle shroud 6408.The axial load will overcome the temporary engagement between thelocking tabs 6412 and the locking members 6414, thus freeing the needleshroud 6408 and enabling the needle shroud 6408 to start its transitionto the retracted position.

In some embodiments, disengaging the locking members 6414 from thelocking tabs 6412 may result in a tactile response, thus providing theuser with haptic feedback. More particularly, upon disengaging thelocking members 6414 from the locking tabs 6412, a small vibration ortremor may result in the sensor applicator 6302, thus indicating to auser that the deployment process has begun. This haptic feedback mayencourage the user to continue to apply pressure to the needle shroud6408.

In some embodiments, one or more sensation features 6512 may be providedat the bottom end of the needle shroud 6408. The sensation features 6512may contact the underlying skin to stimulate the nerve endings on theskin at that location and thereby help to mask the sensation of thesharp 6222 penetrating the skin. In some embodiments, the sensationfeatures 6512 may comprise nubs or small projections defined on the endof the needle shroud 6408.

In FIG. 65C, the needle shroud 6408 has moved a short distance from theextended position and toward the retracted position, thus exposing thesensor 6216 and the sharp 6222 as they extend out of the lower end ofthe needle shroud 6408. More specifically, as the needle shroud 6408 ispressed against the skin, it compresses the skin, and moves relative tothe sensor 6216 and the sharp 6222, which causes the sensor 6216 and thesharp 6222 to extend out of the needle shroud 6408 to penetrate theskin. One advantage of the needle shroud 6408 is its proximity to theinsertion site of the sensor 6216 and the sharp 6222. More particularly,the needle shroud 6408 is able to provide local compression of the skinat the insertion site, which tightens the skin at the insertion site andthereby facilitates a more efficient insertion of the sensor 6216 andthe sharp 6222.

Moving the needle shroud 6408 to the retracted position also moves theupper portion of the needle shroud 6408 relative to the fingers 6414 andthe sharp hub 6224 arranged within the inner chamber 6506 of the needleshroud 6408. Friction between the fingers 6414 and the inner wall of theinner chamber 6506 provides a small amount of resistance while allowingmotion of the housing towards the skin surface, which can be felt by theuser during firing to help drive the sharp 6222 into the underlying skinby applying additional pressure to bypass the force bump.

In FIG. 65D, the needle shroud 6408 has moved to the retracted position,and the bottom end of the needle shroud 6408 may be flush with or insetinto the bottom of the sensor control device 6202. Once the needleshroud 6408 has moved to the retracted position, the fingers 6414 of thesensor retainer 6406 may be positioned outside of the inner chamber 6506and are therefore no longer radially constrained by the needle shroud6408. Consequently, the spring force built up in the driver spring 6410may release and force the sharp hub 6224 against the tops of the fingers6414, which flexes the fingers 6414 radially outward and allows thesharp hub 6224 to move upward relative to the fingers 6414. As the sharphub 6224 moves upward, the sharp 6222 correspondingly retracts out ofthe underlying skin and into the sensor applicator 6302, thus leavingonly the sensor 6216 within the skin.

In some embodiments, the sensor applicator 6302 may provide hapticfeedback to the user that provides an indication that the sensordeployment process is complete. More specifically, haptic or tactilefeedback may be provided to the user when the needle shroud 6408 hasmoved to the retracted position and the sharp 6222 has fully retracted.In such embodiments, release of the driver spring 6410 may provide somedegree of haptic feedback. However, springs, detents, or other elementsmay alternatively (or in addition) be included to also signalfunctionality and a completed firing process. In some applications, theforces generated by the experience may be tailored to be similar totaking a common retractable pen and pushing the thumb actuated“thruster” end against the skin.

FIG. 66 is an enlarged cross-sectional side view of an engagementbetween the sensor retainer 6406 and the sensor control device 6202,according to one or more embodiments. In some embodiments, the collar6214 may be removably coupled to the sensor retainer 6406, whichcorrespondingly retains the sensor control device 6202 to the sensorretainer 6406. In the illustrated embodiment, the sensor retainer 6406may provide or otherwise define one or more first retention features6602 operable to mate with one or more corresponding second retentionfeatures 6604 defined on the collar 6214. In the illustrated embodiment,the first and second retention features 6602, 6604 comprise tabs andcorresponding lips or grooves that receive the tabs. However, the firstand second retention features 6602, 6604 may comprise any type ofremovable coupling or engagement that temporarily couples the sensorcontrol device 6202 to the sensor retainer 6406.

The sensor control device 6302 may be released from the sensor retainer6406 by disengaging the first and second retention features 6602, 6604.This may be accomplished by attaching (sticking) the adhesive layer 6226against the skin. The first and second retention features 6602, 6604 maybe designed so that when the sensor control device 6202 is adhesivelyattached to the skin with the adhesive layer 6226, the engagementbetween the first and second retention features 6602, 6604 may be brokenby retracting the sensor applicator 6302 away from the sensor controldevice 6202. This allows the sensor control device 6202 to separate fromthe sensor applicator 6302 and remain on the body.

In some embodiments, a seal 6606 may seal an interface between the topof the sensor control device 6202 and the bottom of the sensor retainer6406, and thereby help form a sterile barrier for the sensor 6216 andthe sharp 6222. In one embodiment, the seal 6606 may be co-molded orotherwise attached to the top of the sensor control device 6202 or thecollar 6214. In other embodiments, however, the seal 6606 may beco-molded or attached to the bottom of the sensor retainer 6406. In yetother embodiments, the seal 6606 may be a separate component part, suchas an O-ring or the like.

FIG. 67 is an exploded isometric view of another sensor applicator 6702with the sensor control device 6202, according to one or more additionalembodiments. The sensor applicator 6702 may be similar in some respectsto the sensor applicator 6302 of FIGS. 63 and 64A-64B and may thus bebest understood with reference thereto, where like numerals willcorrespond to like components not described again in detail. Similar tothe sensor applicator 6302, for example, the sensor applicator 6702 mayinclude the housing 6304 that may be sized to accommodate the desiccant6404 and the sensor control device 6202 therein. The collar 6214 and thesensor 6216 of the sensor control device 6202 may each be mounted to theelectronics housing 6204 at or within the aperture 6215 defined in theelectronics housing 6204, as generally described above. Moreover, thesensor applicator 6702 may also include the sensor cap 6308 used to helpform a sterile barrier with the collar 6214 and thereby protect thedistal ends of the sensor 6216 and the sharp 6222. As described above,the seal 6504 may help form the sterile barrier by sealing the interfacebetween the top of the sensor cap 6308 and the collar 6214 (or anotherportion of the sensor control device 6202).

A sharp hub 6704 carries the sharp 6222 and may be overmolded onto thesharp 6222, but could alternatively be fabricated from plastic, metal,or another suitable material as a separate component, and bonded,welded, or mechanically attached to the sharp 6222. The sensorapplicator 6702 may also include a sensor retainer 6706, a needle shroud6708, and a driver spring 6710. The sensor retainer 6706 (alternatelyreferred to as a “puck retainer”) may be matable with the housing 6304to help retain the needle shroud 6708, the driver spring 6710, and thesharp hub 6704 generally within or connected to the housing 6304. Morespecifically, the sensor retainer 6706, the needle shroud 6708, thesharp hub 6704, and the driver spring 6710 may all be operativelycoupled to help facilitate deployment of the sensor control device 6202.

In the illustrated embodiment, the driver spring 6710 may be sized to bearranged about the sharp hub 6704, and the sensor retainer 6706 mayprovide a plurality of upwardly extending fingers 6712 (three shown)configured to extend into an inner chamber 6714 defined by the sharp hub6704. The sharp 6222 and the needle shroud 6708 may be extendablethrough the inner chamber 6714, and further extendable through anaperture 6716 defined in the sensor retainer 6706 and the aperture 6215provided in the electronics housing 6204. The needle shroud 6708 may bemovable (actuatable) between an extended position and a retractedposition to deploy the sensor control device 6202 from the sensorapplicator 6702.

As described in more detail below, when the needle shroud 6708 is in theextended position, the fingers 6712 may be radially constrained betweenan outer surface of the needle shroud 6708 and an inner wall of thesharp hub 6704 within the inner chamber 6714, thus preventing the sharphub 6704 (and the sharp 6222) from moving. Once the needle shroud 6708moves to the extended position, however, the fingers 6712 may becomealigned with one or more reliefs 6718 defined on the needle shroud 6708,which allow the fingers 6712 to flex radially inward and release thesharp hub 6704. In some embodiments, the driver spring 6710 may providea spring force that urges the sharp hub 6704 upward and simultaneouslyflexes the fingers 6712 radially inward, which allows the sharp hub 6704to move upward and retract the sharp 6222 into the housing 6304.

FIGS. 68A-68D are progressive cross-sectional side views of the sensorapplicator 6702 depicting example deployment of the sensor controldevice 6202, according to one or more embodiments. User operation(actuation) of the sensor applicator 6702 can cause the needle shroud6708 to move from the extended position, as shown in FIGS. 68A and 68B,to the retracted position, as shown in FIG. 68D. Once the needle shroud6708 reaches the retracted position, the sensor control device 6202 maybe able to be released (discharged) from the sensor retainer 6706.

Referring first to FIG. 68A, an applicator cap 6802 may be removablycoupled to the housing 6304 and may be similar in some respects to theapplicator cap 6306 of FIG. 63. In some embodiments, the interfacebetween the applicator cap 6802 and the housing 6304 may be sealed tohelp protect and shield the adhesive patch 6226 from contamination ordamage prior to deploying the sensor control device 6202. The sensor cap6308 is also depicted extending distally from the bottom of the sensorapplicator 6702 and, more particularly, from the sensor control device6202. The interior 6502 of the sensor cap 6308 may accommodate thedistal ends of the sensor 6216 and the sharp 6222 and the lower portionof the needle shroud 6708 in the extended position. Moreover, the seal6504 may interpose the top of the sensor cap 6308 and the collar 6214 tohelp form a sterile barrier for the sensor 6216 and the sharp 6222.

In FIG. 68B, the applicator cap 6802 and the sensor cap 6308 have beenremoved from the sensor applicator 6702, thereby exposing the needleshroud 6708 and the bottom of the sensor control device 6202. With theneedle shroud 6708 in the extended position, as illustrated, the upperportion of the needle shroud 6708 resides within the housing 6304, whilethe lower portion extends distally through the aperture 6716 defined inthe sensor retainer 6706 and through the aperture 6215 defined throughthe sensor control device 6202. Moreover, the upper portion of theneedle shroud 6708 extends into and through the inner chamber 6714defined within the sharp hub 6704. The upwardly extending fingers 6712of the sensor retainer 6706 extend into the inner chamber 6714 andinterpose the needle shroud 6708 and the inner wall of the inner chamber6714.

As indicated above, the driver spring 6710 may be positioned about anexterior portion of the sharp hub 6704 and may extend between the sharphub 6704 and the sensor retainer 6706. More specifically, the top end ofthe driver spring 6710 may be received within a channel 6806 defined bythe sharp hub 6704, and the bottom end of the driver spring 6710 mayengage the sensor retainer 6706, such as a top surface of the sensorretainer 6706. The driver spring 6710 is compressed between the sharphub 6704 and the sensor retainer 6706 when the needle shroud 6708 in theextended position. The driver spring 6710 is prevented from releasingits spring force and expanding as long as the fingers 6712 are radiallyconstrained between the outer surface of the needle shroud 6708 and theinner wall of the inner chamber 6714. More particularly, the tops of thefingers 6712 may extend radially outward and received within a groove ornotch 6808 defined on the sharp hub 6704. When the tops of the fingers6712 are received within the notch(es) 6808, the sharp hub 6704 may beprevented from moving upward.

Referring briefly to FIG. 69A, depicted is an enlarged schematic view ofthe sharp hub 6704 and the fingers 6712 of the sensor retainer 6706 ofFIG. 67. As illustrated, the tops of each finger 6712 may extend orprotrude radially outward to be received within corresponding notches6808 defined at an upper end of the sharp hub 6704. The fingers 6712extend within the inner chamber 6714 and interpose the outer radialsurface of the needle shroud 6708 and the inner wall of the innerchamber 6714. The sharp hub 6704 is prevented from moving upward as longas the tops of the fingers 6712 are constrained into engagement with thenotches 6808.

Referring briefly to FIGS. 69B and 69C, depicted are enlarged schematicviews of the fingers 6712 interacting with the upper portion of theneedle shroud 6708. In some embodiments, as illustrated, the upperportion (end) of the needle shroud 6708 may define a groove 6902 and adetent profile 6904 that terminates in a force bump 6906. In suchembodiments, the upper ends of the fingers 6712 may provide or otherwisedefine inwardly extending (protruding) lips or features 6908 configuredto interact with the groove 6902, the detent profile 6904, and the forcebump 6906. With the needle shroud 6708 in the extended position, thefeatures 6908 provided on the fingers 6712 may be engaged with andotherwise received by the groove 6902 provided on the needle shroud6708, which helps axially maintain the needle shroud 6708 in theextended position.

The features 6908 must be disengaged from the groove 6902 to allow theneedle shroud 6708 to move to the retracted position and thereby deploythe sensor control device 6202. This can be accomplished by the userpositioning the sensor applicator 6702 (FIG. 68B) at the targetmonitoring location and forcing the bottom of the needle shroud 6708against the skin, which places an axial load on the needle shroud 6708.The axial load will overcome the temporary engagement between the groove6902 and the features 6908, thus freeing the needle shroud 6708 andenabling the needle shroud 6708 to start its upward transition to theretracted position.

As shown in FIG. 69C, the features 6908 have been disengaged from thegroove 6902, and the features 6908 may slide along the detent profile6904 as the needle shroud 6708 moves upward relative to the fingers6712. When the features 6908 locate the force bump 6906, the user mayapply additional pressure to overcome and otherwise bypass the forcebump 6906. In some embodiments, disengaging the features 6908 from thegroove 6902 or bypassing the force bump 6906 may result in a tactileresponse that may be felt by the user, thus providing the user withhaptic feedback. More particularly, upon disengaging the features 6908from the groove 6902 (or bypassing the force bump 6906), a smallvibration or tremor may propagate through the sensor applicator 6702(FIG. 68B), thus indicating to a user that the deployment process hasbegun. This haptic feedback may encourage the user to continue to applypressure to the needle shroud 6708.

Referring again to FIGS. 68A-68D and, more particularly, to FIG. 68C,the needle shroud 6708 has moved from the extended position and towardthe retracted position, thus exposing the sensor 6216 and the sharp 6222as they extend out the lower end of the needle shroud 6708. Morespecifically, as the user presses the needle shroud 6708 against theskin, the needle shroud 6708 moves relative to the sensor 6216 and thesharp 6222, which causes the sensor 6216 and the sharp 6222 to extendout of the bottom of the needle shroud 6708 to penetrate the skin. Oneadvantage of the needle shroud 6708 is its proximity to the insertionsite of the sensor 6216 and the sharp 6222. More particularly, theneedle shroud 6708 is able to provide local compression of the skin atthe insertion site near the sharp 6222, which tightens the skin at theinsertion site and thereby facilitates a more efficient insertion of thesharp 6222 and the sensor 6216.

Moving the needle shroud 6708 to the retracted position also moves theupper portion of the needle shroud 6708 relative to the fingers 6712 ofthe sensor retainer 6706 arranged within the inner chamber 6714 of thesharp hub 6704. Friction between the fingers 6712 and the outer surfaceof the needle shroud 6708 provides a small amount of resistance, whichmay be felt by the user during firing to help drive the sharp 6222 intothe underlying skin without user hesitation.

In FIG. 68D, the needle shroud 6708 has moved to the retracted position,which aligns the fingers 6712 with the reliefs 6718 defined in thesidewall of the needle shroud 6708. Aligning the fingers 6712 with thereliefs 6718 allows the fingers 6712 to flex radially inward into thereliefs 6718 as the driver spring 6710 release and forces the sharp hub6704 against the tops of the fingers 6712. Once the fingers 6712 enterthe reliefs 6718, the sharp hub 6704 may be released and the springforce of the driver spring 6710 may move the sharp hub 6704 upwardrelative to the fingers 6712, which correspondingly retracts the sharp6222 into the sensor applicator 6702, thus leaving only the sensor 6216within the skin.

In some embodiments, the sensor applicator 6702 may provide hapticfeedback to the user that provides an indication that the sensordeployment process is complete. More specifically, haptic or tactilefeedback may be provided to the user when the needle shroud 6708 movesto the retracted position and the sharp 6222 has fully retracted. Insuch embodiments, release of the driver spring 6710 may provide somedegree of haptic feedback that propagates through the sensor applicator6702 to be felt by the user. However, springs, detents, or otherelements may alternatively (or in addition) be included to also signalfunctionality and a completed firing process. In some applications, theforces generated by the experience may be tailored to be similar totaking a common retractable pen and pushing the thumb actuated“thruster” end against the skin.

FIGS. 70A and 70B are enlarged cross-sectional side views of exampleengagement between the sensor retainer 6706 and the sensor controldevice 6202, according to one or more embodiments. In some embodiments,the collar 6214 may be removably coupled to the sensor retainer 6706,which correspondingly removably couples the sensor control device 6202to the sensor retainer 6706. In the illustrated embodiment, the sensorretainer 6706 may provide or otherwise define one or more firstretention features 7002 operable to mate with one or more correspondingsecond retention features 7004 defined on the collar 6214. In theillustrated embodiment, the first retention features 7002 comprise tabsthat extend downwardly through the aperture 6716 of the sensor retainer6706, and the second retention features 7004 comprise corresponding lipsor grooves that receive the tabs. However, the first and secondretention features 7002, 7004 may comprise any type of removablecoupling or engagement that temporarily couples the sensor controldevice 6202 to the sensor retainer 6706.

As the needle shroud 6708 moves upward toward the retracted position,the first retention features 7002 may be radially constrained between anouter surface 7006 of the needle shroud 6708 and the collar 6214, whichprevents the first retention features 7002 from disengaging from thesecond retention features 7004. Once the needle shroud 6708 reaches theretracted position, however, the first retention features 7002 mayaxially align with corresponding relief pockets 7008 defined in thesidewall of the needle shroud 6708. Once the first retention features7002 axially align with the relief pockets 7008, the first retentionfeatures 7002 may be able to flex radially inward into the reliefpockets 7008, which allows the sensor control device 6302 to be releasedfrom the sensor retainer 6706, as is shown in FIG. 70B. Flexing thefirst retention features 7002 radially inward may disengage the firstand second retention features 7002, 7004, thus allowing the sensorcontrol device to release from the sensor retainer 6706.

In some embodiments, the first and second retention features 7002, 7004may be disengaged by attaching (sticking) the adhesive layer 6226against the skin and pulling back on the sensor applicator 6702 (FIGS.68A-68D). More specifically, the first and second retention features7002, 7004 may be designed so that when the sensor control device 6202is adhesively attached to the skin with the adhesive layer 6226, theengagement between the first and second retention features 7002, 7004may be broken by retracting the sensor applicator 6702 away from theplaced sensor control device 6202. This allows the sensor control device6202 to separate from the sensor applicator 6702 and remain on the body.

FIGS. 71A and 71B are isometric and cross-sectional side views,respectively, of an example sensor retainer 7100, according to one ormore embodiments. The sensor retainer 7100 may be similar in somerespects to the sensor retainers 6406, 6706 of FIGS. 64A-64B and 67,respectively, and therefore may be best understood with referencethereto. Similar to the sensor retainers 6406, 6706, for example, thesensor retainer 7100 may be configured to retain the sensor controldevice 6202 prior to deployment within a sensor applicator, such as anyof the sensor applicators 102, 6302, 6702 of FIGS. 1, 63, 67,respectively, described herein.

In contrast to the sensor retainers 6406, 6706 of FIGS. 64A-64B and 67,however, the sensor retainer 7100 may interact with a sharp hub 7102that carries the sharp 6222 to releasably couple the sensor controldevice 6202 to the sensor retainer 7100. As illustrated, the sensorretainer 7100 may define an aperture 7104 through which a lower portionof the sharp hub 7102 (and the sharp 6222) may extend. The aperture 7104may align with the aperture 6215 defined in the electronics housing 6204of the sensor control device 6202, and the lower portion of the sharphub 7102 may also extend into the aperture 6215 when the sensor controldevice 6202 is removably (releasably) coupled to the sensor retainer7100.

As illustrated, the sensor retainer 7100 may define or otherwise provideone or more arms 7106 that extend downwardly into the aperture 7104 andpast the bottom of the sensor retainer 7100. As best seen in FIG. 71B,each arm 7106 may provide or otherwise define one or more firstretention features 7108 operable to mate with one or more correspondingsecond retention features 7110 defined on or otherwise provided by thesensor control device 6202. In some embodiments, the second retentionfeatures 7110 may be provided by the collar 6214 (FIGS. 62 and 67)positioned within the aperture 6215, but could alternatively be providedon another part of the sensor control device 6202, without departingfrom the scope of the disclosure.

In the illustrated embodiment, the first retention features 7108 may beprovided at the bottom end of the arms 7106 and may comprise tabs orprotrusions that extend (project) radially outward. The second retentionfeature 7110 may comprise a lip or annular shoulder extending radiallyinward at the aperture 6215 to receive and otherwise mate with the firstretention features 7108. Those skilled in the art will readilyappreciate, however, that the first and second retention features 7108,7110 may comprise any type of removable coupling or engagement thattemporarily couples the sensor control device 6202 to the sensorretainer 6706, without departing from the scope of the disclosure.

FIGS. 72A and 72B are enlarged cross-sectional side views of the sensorretainer 7100 retaining the sensor control device 6202. As illustrated,the lower portion of the sharp hub 7102 is received within the aperture7104 of the sensor retainer 7100 and also extends at least partiallythrough the aperture 6215 of the sensor control device 6202. The sharphub 7102 is shown in FIGS. 72A-72B in an extended position, and may bemovable to a retracted position where the sharp hub 7102 moves out ofaxial alignment with the apertures 6215, 7104. Moving the sharp hub 7102to the retracted position may be accomplished through user interventionin firing the sensor applicator that houses the sensor control device6202. Once the sensor applicator is fired, a spring or other biasingdevice (not shown) operatively coupled to the sharp hub 7102 may causethe sharp hub 7102 to quickly move upwardly relative to the sensorretainer 7100.

With the sharp hub 7102 in the extended position, as depicted, the firstretention features 7108 may be engaged with or otherwise mated to thesecond retention feature 7110. Moreover, when the sharp hub 7102 is inthe extended position, the arms 7106 may be radially constrained betweenthe sidewall of the sharp hub 7102 and the second retention feature7110, which prevents the first retention features 7108 from disengagingfrom the second retention features 7110. Once the sharp hub 7102 movesto the retracted position, however, the arms 7106 will no longer bebacked by the sidewall of the sharp hub 7102, thus enabling the arms7106 to flex radially inward to disengage the first and second retentionfeatures 7108, 7110 and thereby release the sensor control device 6302.

In some embodiments, the arms 7106 may flex radially inward to disengagethe first and second retention features 7108, 7110 by attaching(sticking) the adhesive layer 6226 against the skin and pulling back onthe sensor applicator that carries the sensor control device 6202. Morespecifically, the first and second retention features 7108, 7110 may bedesigned so that when the sensor control device 6202 is adhesivelyattached to the skin with the adhesive layer 6226, the engagementbetween the first and second retention features 7108, 7110 may be brokenby retracting the sensor applicator away from the placed sensor controldevice 6202. This allows the sensor control device 6202 to separate fromthe sensor applicator and remain on the body.

Electronics housings of prior sensor control devices are commonlymanufactured of rigid plastic materials, and are retained within asensor applicator by sensor retainers that have a plurality of flexiblearms. Such electronics housings often define a plurality ofsemi-hemispherical notches or grooves on the outer periphery of theelectronics housing that are sized to receive the ends of the flexiblearms. According to embodiments of the present disclosure, however, theelectronics housing 6204 of the sensor control device 6202 may beconstructed of flexible or soft materials, such as a soft encapsulant, afoam, or small injection molded components. With flexible or softmaterials, it can be a challenge to define features on the exterior ofthe electronics housing that can be used to retain the sensor controldevice 6202 to the sensor retainer 7100 during shipment and during theinsertion process.

Accordingly, the sensor retainer 7100 includes the arms 7106 that helpgrasp and retain the sensor control device at the matable first andsecond retention features 7108, 7110. The arms 7106 are flexible andcapable of deflecting away from the second retention feature 7110 whenthe sensor control device 6202 is pulled from the sensor applicator byadhesive attachment to the skin. Prior to insertion, however, the arms7106 are prevented from deflecting and releasing the sensor controldevice 6202 by the presence of the sharp hub 7102 extended within(through) the apertures 6215, 7104. The sensor retainer 7100 may retainthe sensor control device 6202 due to the arms 7106 not being able todeflect radially inwards. During the firing (insertion) process,however, and when the sharp 6222 and the sharp hub 7102 are retractedfrom the skin, the arms 7106 are no longer back supported and will bedeflected as the sensor control device 6202 is pulled from the sensorapplicator.

In addition to providing a method to retain the sensor control device6202 in the sensor applicator, the features of the sensor retainer 7100enable a more compact applicator design by replacing the flexible armsof conventional sensor retainers. By relocating the flexible retentionarms to the apertures 6215, 7104, the overall size of the sensorapplicator may be reduced.

FIGS. 73A and 73B are side and cross-sectional side views, respectively,of an example sensor applicator 7302, according to one or moreembodiments. The sensor applicator 7302 may be similar in some respectsto the sensor applicator 102 of FIG. 1 and, therefore, may be designedto deliver (fire) a sensor control device, such as the sensor controldevice 6202. FIG. 73A depicts how the sensor applicator 7302 might beshipped to and received by a user, and FIG. 73B depicts the sensorcontrol device 6202 arranged within the interior of the sensorapplicator 7302.

As shown in FIG. 73A, the sensor applicator 7302 includes a housing 7304and an applicator cap 7306 removably coupled to the housing 7304. Insome embodiments, the applicator cap 7306 may be threaded to the housing7304 and include a tamper ring 7308. Upon rotating (e.g., unscrewing)the applicator cap 7306 relative to the housing 7304, the tamper ring7308 may shear and thereby free the applicator cap 7306 from the sensorapplicator 7302.

In FIG. 73B, the applicator cap 7306 has been removed from the housing7304, thus exposing a sheath 7310 that generally surrounds the sensorcontrol device 6202. During firing of the sensor applicator 7302, thesheath 7310 may be actuated (e.g. pushed or forced into the housing7304), which causes the sensor control device 6202 to be discharged fromthe sensor applicator 7302.

In the illustrated embodiment, the sensor control device 6202 mayinclude a sensor cap 7314 removably coupled to the sensor control device6202 at or near the bottom of the electronics housing 6204. The sensorcap 7314 may help provide or facilitate a sealed or sterile barriersurrounding and protecting the exposed portions of the sensor 6216 andthe sharp 6222. As illustrated, the sensor cap 7314 may comprise agenerally cylindrical and elongate body having a first end 7315 a and asecond end 7315 b opposite the first end 7315 a. The first end 7315 amay be open to provide access into an inner chamber 7316 defined withinthe body, and the second end 7315 b may be closed and may provide orotherwise define one or more engagement features 7318.

In some embodiments, the sensor cap 7314 may be removably coupled to thesensor control device 6202 by being coupled to a sharp hub 7320 thatcarries the sharp 6222 and extends through the electronics housing 6204.In such embodiments, the sharp hub 7320 may extend past the bottom ofthe electronics housing 6204 to provide a location where the sensor cap7314 might engage the sharp hub 7320. Consequently, at least a portionof the sharp hub 7320 may be extend into the inner chamber 7316 of thesensor cap 7314. Prior to delivering the sensor control device 6202 tothe target monitoring location on the user's skin, the sensor cap 7314may be separated from the sharp hub 7320. In some embodiments, thesensor cap 7314 may be removably coupled to the sharp hub 7320 via aninterference or friction fit. In other embodiments, the sensor cap 7314may be threaded to the sharp hub 7320. In yet other embodiments, thesensor cap 7314 may be removably coupled to the sharp hub 7320 with afrangible member (e.g., a shear ring) or substance that may be brokenwith minimal separation force (e.g., axial or rotational force). In suchembodiments, for example, the sensor cap 7314 may be secured to thesharp hub 7320 with a tag (spot) of glue or a dab of wax.

In some embodiments, however, the sharp hub 7320 may not extend past thebottom of the electronics housing 6204. In such embodiments, the sensorcap 7314 may alternatively be removably coupled to another portion ofthe sensor control device 6202, such as the collar 6214 (FIGS. 62 and67) or the mount 6208 (FIG. 62). In such embodiments, the sensor cap7314 may be removably coupled to the collar 6214 or the mount 6208 (orboth) via an interference or friction fit, threading, with a frangiblemember or substance, or any combination thereof.

The inner chamber 7316 may be sized and otherwise configured to receivethe distal ends of the sensor 6216 and the sharp 6222. Moreover, theinner chamber 7316 may be sealed to isolate the sensor 6216 fromsubstances that might adversely interact with the chemistry of thesensor 6216. More specifically, the inner chamber 7316 may be sealed atthe interface between the first end 7315 a of the sensor cap 7312 andthe location where it is removably coupled to the sensor control device6202. In some embodiments, a desiccant may be present within the innerchamber 7316 to help maintain preferred humidity levels.

As illustrated, the sensor applicator 7302 may further include aninternal applicator cover 7322 that may extend at least partially intothe sheath 7310. The internal applicator cover 7322 may comprise agenerally cylindrical body having a first end 7324 a and a second end7324 b opposite the first end 7324 a. A sidewall of the internalapplicator cover 7322 may extend between the first and second ends 7324a,b and into the interior of the sheath 7310 when the internalapplicator cover 7322 is coupled to the sensor applicator 7302. Theinternal applicator cover 7322 may be open at the first end 7324 a toprovide access to a cover interior 7326. The second end 7324 b may beclosed and may provide or otherwise define a gripping interface 7328.

In some embodiments, the internal applicator cover 7322 may be removablycoupled to the sheath 7310, such as via an interference fit or athreaded engagement. In other embodiments, the applicator cap 7306 (FIG.73A) may be used to help retain the internal applicator cover 7322within the sensor applicator 7302 while applicator cap 7306 is coupled(threaded) to the housing 7304. In yet other embodiments, the internalapplicator cover 7322 may be coupled to the sensor cap 7312. Moreparticularly, the internal applicator cover 7322 may provide orotherwise define receiving features 7330 within the cover interior 7326at or near the second end 7324 b. The receiving features 7330 may beconfigured to receive the second end 7315 b of the sensor cap 7312 and,more particularly, mate with the engagement features 7318 of the sensorcap 7312.

The internal applicator cover 7322 may be removed from the sensorapplicator 7302 by a user grasping the gripping interface 7328 androtating and/or pulling on the internal applicator cover 7322 relativeto the shroud 7310 and out of engagement with the sensor applicator7302. As described below, as the internal applicator cover 7322 isremoved, engagement between the receiving features 7330 and theengagement features 7318 causes the sensor cap 7312 to also be removedfrom the sensor control device 6202, thus exposing the sensor 6216 andthe sharp 6222 and readying the sensor control device 6202 for firing.

FIGS. 74A and 74B are isometric top and bottom views, respectively, ofthe internal applicator cover 7322. As depicted, the receiving features7330 may be provided within the cover interior 7326 at or near thebottom of the internal applicator cover 7322. As indicated above, thereceiving features 7330 may be designed to receive the lower end 7315 b(FIG. 73B) of the sensor cap 7312 (FIG. 73B) and mate with theengagement features 7318 (FIG. 73B). As will be appreciated, many designvariations of the engagement features 7318 and the receiving features7330 may be employed, without departing from the scope of thedisclosure. Any design may be used that allows the engagement features7318 to be received by the receiving features 7330, and subsequentlyprevent the sensor cap 7312 from separating from the receiving features7330 upon removing the internal applicator cover 7322.

In some embodiments, for example, the engagement and receiving features7318, 7330 may comprise a threaded interface or a keyed mating profilethat allows initial engagement but prevents subsequent disengagement. Inthe illustrated embodiment, the receiving features 7330 include one ormore compliant members 7402 that are expandable or flexible to receivethe engagement features 7318. The receiving features 7330 may alsoinclude two or more planar members 7404 configured to receive the lowerend 7315 b (FIG. 73B) of the sensor cap 7312 (FIG. 73B) and prevent thesensor cap 7312 from rotating relative to the internal applicator cover7322.

In FIG. 74B, the gripping interface 7328 may comprise an upright flange7406 extending across a depression 7408 formed into the second end 7324b. A user may be able to grip the internal applicator cover 7322 withthe thumb and forefinger at the upright flange 7406, and apply arotational or axial load to the internal applicator cover 7322 via thegripping interface 7328.

FIG. 75 is an isometric view of an example embodiment of the sensor cap7312, according to one or more embodiments. In some embodiments, asillustrated, the first end 7315 a of the sensor cap 7312 may provide ordefine a reduced-diameter portion 7502 that may help facilitateremovable coupling engagement to the sensor control device 6202 (FIG.73B).

At the second end 7315 b, the engagement features 7318 may comprise, forexample, an enlarged head or annular ring 7504 that can interact withthe compliant members 7402 (FIG. 74A) of the internal applicator cover7322 (FIG. 74A). The annular ring 7504 may alternatively comprise one ormore radial protrusions. In some embodiments, the engagement features7318 may also provide or otherwise define two or more planar surfaces7506 configured to interact with the planar members 7404 (FIG. 74A) ofthe internal applicator cover 7322. In at least one embodiment, theplanar surfaces 7506 may provide a hexagonal shape to the second end7315 b and may mate with the planar members 7404.

FIG. 76 is an isometric, cross-sectional side view of the sensor cap7312 received by the internal applicator cover 7322, according to one ormore embodiments. As illustrated, the engagement features 7318 arereceived within the receiving features 7330 of the internal applicatorcover 7322. More particularly, the annular ring 7504 is received by thecompliant members 7402, and the compliant members 7402 may comprise, forexample, a collet-type device that includes a plurality of compliantfingers configured to flex radially outward to receive the annular ring7504. In other embodiments, however, the compliant members 7402 maycomprise an elastomer or another type of compliant material configuredto expand radially to receive the annular ring 7504. Accordingly, as thesensor cap 7312 is extended into the receiving features 7330, thecompliant members 7402 may flex (expand) radially outward to receive theengagement features 7318. Once the annular ring 7504 bypasses thecompliant members 7402, the compliant members 7402 flex back to theirnatural state and thereby prevent the sensor cap 7312 from disengagingfrom the internal applicator cover 7322.

Mating the engagement features 7318 to the receiving features 7330 mayalso include mating the planar surfaces 7502 of the sensor cap 7312 withthe planar members 7404 of the internal applicator cover 7322. Theopposing planar members and surfaces 7404, 7502 may bind the sensor cap7312 rotationally such that the sensor cap 7312 is unable to rotaterelative to the internal applicator cover 7322.

FIG. 77 shows progressive removal of the applicator cap 7306 and theinternal applicator cover 7322 from the sensor applicator 7302,according to one or more embodiments. Moving from left to right in FIG.77, the applicator cap 7306 may be removed by unscrewing it from thehousing 7304. Removing the applicator cap 7306 exposes the sheath 7310and the bottom of the internal applicator cover 7322. At this point, thesensor cap 7312 remains removably coupled to the sensor control device6202 within the sensor applicator 7302. Consequently, the sterilebarrier facilitated by the sensor cap 7312 is not broken by removal ofthe applicator cap 7306, and the sensor 6216 and the sharp 6222 remainprotected. This feature may prove advantageous in the event the userchanges his/her mind about firing the sensor applicator 7302 (i.e.,deploying the sensor control device 6202) after removing the applicatorcap 7306. In the event of a decision change, the sensor 6216 and thesharp 6222 remain protected within the sensor cap 7312, which is coupledto the internal applicator cover 7322.

To be able to properly fire the sensor applicator 7302 and therebydeploy the sensor control device 6202, the internal applicator cover7322 must first be removed. As mentioned above, this can be done by theuser gripping the internal applicator cover 7322 at the grippinginterface 7328. The user may then apply a rotational or axial load tothe internal applicator cover 7322 via the gripping interface 7328 toremove the internal applicator cover 7322. Upon removing the internalapplicator cover 7322 from the sensor applicator 7302, the receivingfeatures 7330 (FIG. 74A) of the internal applicator cover 7322 mayretain the engagement features 7318 of the sensor cap 7312 and therebyprevent the sensor cap 7312 from separating from the receiving features7330. Instead, removing the internal applicator cover 7322 from thesensor applicator 7302 will simultaneously detach the sensor cap 7312from the sensor control device 6202, and thereby expose the distalportions of the sensor 6216 and the sharp 6222.

FIG. 78 is a schematic diagram of an example sensor applicator 7800,according to one or more additional embodiments of the presentdisclosure. Similar to the other sensor applicators described herein,the sensor applicator 7800 may be configured to house and subsequentlydeploy a sensor control device 7802, which may be similar in somerespects to any of the sensor control devices described herein.Alternatively, the sensor control device 7802 may comprise a type ofmedical device, a health care product, or a system that might requireterminal sterilization of specific component parts. Example medicaldevices or health care products that may incorporate the principles ofthe present disclosure include, but are not limited to, ingestibleproducts, cardiac rhythm management (CRM) devices, under-skin sensingdevices, externally mounted medical devices, or any combination thereof.

In the illustrated embodiment, the sensor control device 7802 includes ahousing 7804, a part 7806 requiring sterilization, one or more radiationsensitive components 7808, and a battery 7810 that provides power to thesensor control device 7802. In the illustrated embodiment, the radiationsensitive component 7808 may comprise one or more electronic modulessuch as, but not limited to, a data processing unit (e.g., anapplication specific integrated circuit or ASIC), a resistor, atransistor, a capacitor, an inductor, a diode, and a switch.

In some embodiments, the part 7806 may comprise the sensor 6216 and thesharp 6222 described herein. As illustrated, the part 7806 may extend atan angle relative to the housing 7804, but could alternatively extendperpendicular to the housing 7804. In the illustrated embodiment, thepart 7806 is arranged within a sterile chamber 7812 to protect thesensor 6216 and the sharp 6222 from external contamination. In someembodiments, the sterile chamber 7812 may have a desiccant arrangedtherein to help promote preferred humidity conditions.

The sensor 6216 and the sharp 6222 may be sterilized prior to beingassembled in the sensor applicator 7800, or alternatively whileassembled in the sensor applicator 7800. In at least one embodiment, thesensor 6216 and the sharp 6222 may be subjected to radiationsterilization to properly sterilize the part 7806 for use. Suitableradiation sterilization processes include, but are not limited to,electron beam (e-beam) irradiation, gamma ray irradiation, X-rayirradiation, or any combination thereof.

In some embodiments, the sensor control device 7802 may include abarrier shield 7814 positioned within the housing 7804 to help blockradiation (e.g., electrons) from propagating within the housing 7804toward the radiation sensitive components 7808. The barrier shield 7814may be made of a material that reduces or eliminates radiation frompenetrating therethrough and thereby damaging the radiation sensitivecomponents 7808 within the housing 7804. The barrier shield 7814 may bemade of a material having a density sufficient to absorb the dose of thebeam energy being delivered.

In some embodiments, the sterile chamber 7812 may be comprise a cap thatencapsulates the sensor 6216 and the sharp 6222 to provide a sealedbarrier that protects exposed portions of the part 7806 until the part7806 is placed in use. In such embodiments, the sterile chamber 7812 maybe removable or detachable to expose the sensor 6216 and the sharp 6222,as described below. Moreover, in such embodiments, the cap may be madeof a material that permits propagation of radiation therethrough tofacilitate radiation sterilization of the part 7806. Suitable materialsfor the sterile chamber 7812 include, but are not limited to, anon-magnetic metal (e.g., aluminum, copper, gold, silver, etc.), athermoplastic, a ceramic, rubber (e.g., ebonite), a composite material(e.g., fiberglass, carbon fiber reinforced polymer, etc.), an epoxy, orany combination thereof. In some embodiments, the sterile chamber 7812may be transparent or translucent, but can otherwise be opaque, withoutdeparting from the scope of the disclosure.

In other embodiments, the sterile chamber 7812 may comprise a chamber orcompartment defined within one or both of the sensor applicator 7800 andthe sensor control device 7802. In such embodiments, the sterile chamber7812 may include a microbial barrier positioned at one or both ends ofthe sterile chamber 7812. More specifically, the sterile chamber 7812may provide or include an upper microbial barrier 7818 a and a lowermicrobial barrier 7818 b opposite the upper microbial barrier 7818 a.The upper and lower microbial barriers 7818 a,b may help seal thesterile chamber 7812 and thereby isolate the sensor 6216 and the sharp6222 from external contamination. The microbial barriers 7818 a,b may bemade of a radiation permeable material, such as a synthetic material(e.g., a flash-spun high-density polyethylene fiber). One examplesynthetic material comprises TYVEK®, available from DuPont®. In otherembodiments, however, the microbial barriers 7818 a,b may comprise, butare not limited to, tape, paper, film, foil, or any combination thereof.

In some embodiments, the part 7806 may be deployable and otherwisemovable relative to the sensor applicator 7800. In such embodiments, thesensor 6216 and the sharp 6222 may be advanced distally out of thesterile chamber 7812 and past the bottom of the electronics housing 7804to allow the sensor 6216 and the sharp 6222 to be transcutaneouslyreceived beneath a user's skin. Distally advancing the part 7806 may beaccomplished via a variety of mechanical or electromechancial means. Insome embodiments, for example, the sensor applicator 7800 may include aplunger 7816 configured to advance distally to push the sensor 6216 andthe sharp 6222 out of the sterile chamber 7812. In such embodiments, theplunger 7816 may also be configured to attach to the sharp 6222 andsubsequently retract the sharp 6222 while leaving the sensor 6216extended. During operation, the plunger 7816 may penetrate the uppermicrobial barrier 7818 a and force the sensor 6216 and the sharp 6222distally through the lower microbial barrier 7818 b.

In other embodiments, the part 7806 may be advanced distally out of thesterile chamber 7812 using a magnetic coupling. More specifically, thesensor applicator 7800 may include a driver magnet 7820 movable withinthe sensor applicator 7800 and magnetically coupled to a driven magnet7822 disposed on the part 7806, such as on an upper end of the sharp6222. The driver magnet 7820 may be configured to advance distally andsimultaneously push the sensor 6216 and the sharp 6222 out of thesterile chamber 7812 as magnetically coupled to the driven magnet 7822.Once the sensor 6216 is properly placed, the driver magnet 7820 may beretracted proximally and simultaneously retract the sharp 6222 in thesame direction while leaving the sensor 6216 extended. During operation,the driver magnet 7820 may cause the sensor 6216 and the sharp 6222 topenetrate distally through the lower microbial barrier 7818 b.

In embodiments where the sterile chamber 7812 comprises a cap, theplunger 7816 may also be operable to discharge or push the cap out ofthe sensor applicator 7800. In such embodiments, a user may commence thefiring process by priming the sensor applicator 7800, which may causethe cap to be discharged from the sensor applicator 7800. Furtheractuation of the sensor applicator 7800 by the user may cause the sensor6216 and the sharp 6222 to be fully extended for subcutaneousimplantation. In other embodiments, the cap may be removed eitherautonomously (e.g., it falls off or breaks away during firing) or theuser may manually remove it by hand.

In some embodiments, the sensor applicator 7800 may further include anelectrical connector 7824 in electrical communication with theelectronics of the sensor control device 7802, such as the radiationsensitive components 7808. In at least one embodiment, the electricalconnector 7824 may comprise one or more elastic pins made of aconductive polymer (e.g., a carbon impregnated polymer) and configuredto facilitate electrical communication between the sensor 6216 and theradiation sensitive component 7808. In such embodiments, the sensor 6216may include one or more connectors 7826 alignable with the electricalconnector 7824 when the part 7806 is advanced distally, as describedabove. Moreover, in embodiments where the sterile chamber 7812 comprisesa cap, the electrical connector 7824 may be flexible to allow the cap topass by the electrical connector 7824 until the connectors 7826 alignwith the electrical connector 7824.

FIG. 79 is an exploded view of an example sensor control device 7900,according to one or more additional embodiments. The sensor controldevice 7900 may be similar in some respects to any of the sensor controldevices described herein. For example, the sensor control device 7900may include a housing 7902 that contains or otherwise houses a battery7904 that powers the sensor control device 7900 and one or moreradiation sensitive components 7906. The radiation sensitive component7906 may be similar to the radiation sensitive component 7808 of FIG.78, and therefore will not be described again. In some embodiments, thehousing 7902 may be made of a flexible or deformable material.

The sensor control device 7900 may further include a sensor module 7908that may be coupled to the housing 7902 to form the assembled sensorcontrol device 7900. As illustrated, the sensor module 7908 may includethe sensor 6216 and the sharp 6222 extending distally therefrom. In theillustrated embodiment, the sensor 6216 and the sharp 6222 extend at anangle relative to the housing 7902, but could alternatively extendperpendicular to the housing 7902.

The sensor module 7908 may be sterilized separate from the housing 7902to prevent damage to the radiation sensitive components 7906. Followingsterilization, the sensor module 7908 may be paired or coupled to thehousing 7902 via a variety of permanent or removable attachment means.In some embodiments, for example, the sensor module 7908 may be coupledto the housing 7902 via a snap-fit engagement, an interference fit, orusing one or more mechanical fasteners. In other embodiments, however,the sensor module 7908 may be coupled to the housing 7902 using anadhesive, sonic welding, or laser welding. Pairing the sensor module7908 to the housing 7902 may be done during manufacturing or may beaccomplished by a user prior to deploying the sensor control device.

Coupling the sensor module 7908 to the housing 7902 may also facilitatecommunication between the sensor 6216 and the radiation sensitivecomponents 7906. More particularly, in some embodiments, the sensormodule 7908 may include one or more sensor contacts 7910 alignable withone or more electrical connectors 1912 provided on the housing 7902 whenthe sensor module 7908 is coupled to the housing 7902. The sensorcontacts 7910 and the electrical connectors 1912 may comprise one ormore elastic pins made of a conductive polymer (e.g., a carbonimpregnated polymer) and configured to facilitate electricalcommunication between the sensor 6216 and the radiation sensitivecomponent 7906.

FIG. 80 is a bottom view of one embodiment of the sensor control device7900 of FIG. 79. As illustrated, the housing 7902 exhibits a generallypolygonal cross-sectional shape and, more particularly, a triangularshape with rounded corners. In other embodiments, however, the housing7902 may exhibit other cross-sectional shapes including, but not limitedto, circular, oval, ovoid, or other polygonal shapes (e.g., square,rectangular, pentagonal, etc.), without departing from the scope of thedisclosure.

In the illustrated embodiment, the sensor module 7908 may be coupled tothe housing 7902 via a snap-in or snap-fit engagement. Morespecifically, the housing 7902 may define a cavity 8002 sized to receivethe sensor module 7908, and one or both of the housing 7902 and thesensor module 7908 may define or otherwise provide tabs 8004 configuredto matingly engage when the sensor module 7908 is received within thecavity 8002. The tabs 8004 may mate to secure the sensor module 7908within the cavity 8002. As will be appreciated, the tabs 8004 may bereplaced with any other type of device or mechanism that facilitates asnap-in or snap-fit engagement, without departing from the scope of thedisclosure. As indicated above, coupling the sensor module 7908 to thehousing 7902 may be done during manufacturing or may be accomplished bya user prior to deploying the sensor control device.

Embodiments disclosed herein include:

X. A sensor applicator that includes a housing and a sensor retainerarranged within the housing, a sensor control device removably coupledto the sensor retainer and including an electronics housing, a sensorarranged within the electronics housing and extending from a bottom ofthe electronics housing, and a sharp hub that carries a sharp extendingthrough the electronics housing and from the bottom of the electronicshousing. The sensor application further includes a needle shroudextendable through the sensor retainer and the electronics housing andmovable between an extended position, where the needle shroud extendspast the bottom of the electronics housing and covers distal ends of thesensor and the sharp, and a retracted position, where the needle shroudretracts into the housing and thereby exposes the distal ends of thesensor and the sharp.

Y. A method of deploying a sensor control device from a sensorapplicator that includes positioning the sensor applicator adjacent atarget monitoring location, the sensor applicator including a housingand a sensor retainer arranged within the housing, wherein the sensorcontrol device is removably coupled to the sensor retainer and includesan electronics housing, a sensor arranged within the electronics housingand extending from a bottom of the electronics housing, and a sharp hubthat carries a sharp extending through the electronics housing and fromthe bottom of the electronics housing. The method further includesaligning a needle shroud with the target monitoring location, the needleshroud extending through the sensor retainer and the electronicshousing, engaging the needle shroud against the target monitoringlocation to move the needle shroud from an extended position, where theneedle shroud extends past the bottom of the electronics housing andcovers distal ends of the sensor and the sharp, and pushing on thesensor applicator to move the needle shroud to a retracted position,where the needle shroud retracts into the housing and exposes the distalends of the sensor and the sharp to transcutaneously receive the sensorat the target monitoring location.

Each of embodiments X and Y may have one or more of the followingadditional elements in any combination: Element 1: further comprising asensor cap defining an inner chamber that receives the distal ends ofthe tail and the sharp and forms a sterile barrier that protects thedistal ends of the sensor and the sharp. Element 2: further comprisingan applicator cap removably coupled to the housing, wherein theapplicator cap and the sensor cap are simultaneously removable from thehousing. Element 3: wherein the sensor cap extends from the sensorcontrol device. Element 4: wherein the sensor control device furtherincludes a collar coupled to the electronics housing, and wherein thesensor cap is removably coupled to the collar. Element 5: wherein thesensor cap provides a gripping interface for a user to grasp onto andremove the sensor cap from the sensor applicator. Element 6: wherein theneedle shroud is received within the sensor cap when the needle shroudis in the extended position. Element 7: further comprising one or morefirst retention features provided on the sensor retainer, one or moresecond retention features provided on the sensor control device andmatable with the one or more first features, wherein disengaging the oneor more second retention features from the one or more first featuresdeploys the sensor control device for use. Element 8: wherein the sensorretainer provides a plurality of upwardly extending fingers engageablewith the sharp hub to prevent the sharp hub from moving relative to thesensor retainer when the needle shroud is in the extended position.Element 9: wherein the plurality of fingers are extendable into an upperportion of the needle shroud and interpose the sharp hub and an innerwall of the upper portion of the needle shroud when the needle shroud isin the extended position. Element 10: further comprising a driver springcompressed between the sharp hub and the sensor retainer when the needleshroud is in the extended position, wherein moving the needle shroud tothe retracted positon allows the driver spring to expand and move thesharp hub to retract the sharp into the housing. Element 11: wherein theplurality of fingers are extendable into the sharp hub and interpose theneedle shroud and an inner wall of the sharp hub when the needle shroudis in the extended position. Element 12: further comprising a driverspring compressed between the sharp hub and the sensor retainer when theneedle shroud is in the extended position, wherein moving the needleshroud to the retracted positon allows the driver spring to expand andmove the sharp hub to retract the sharp into the housing. Element 13:wherein the needle shroud defines a groove at an upper end and theplurality of fingers provide inwardly extending features engageable withthe groove to help maintain the needle shroud in the extended position.Element 14: wherein the sensor retainer includes one or more lockingtabs matable with one or more locking members provided on the needleshroud to secure the needle shroud in the extended position.

Element 15: further comprising forming a sterile barrier with a sensorcap that receives the distal ends of the tail and the sharp, wherein theneedle shroud is received within the sensor cap when the needle shroudis in the extended position, and removing the sensor cap prior toengaging the needle shroud against the target monitoring location.Element 16: wherein one or more first retention features provided on thesensor retainer are matable with one or more second retention featuresprovided on the sensor control device to couple the sensor controldevice to the sensor retainer, the method further comprising adhesivelyattaching the sensor control device to the target monitoring location,and pulling the sensor applicator away from the target monitoringlocation to disengage the one or more second retention features from theone or more first retention features and thereby detach the sensorcontrol device from the sensor retainer. Element 17: wherein the sensorretainer provides a plurality of upwardly extending fingers engageablewith the sharp hub, the method further comprising preventing the sharphub from moving relative to the sensor retainer with the plurality offingers when the needle shroud is in the extended position. Element 18:wherein the plurality of fingers are extendable into an upper portion ofthe needle shroud and interpose the sharp hub and an inner wall of theupper portion of the needle shroud when the needle shroud is in theextended position, the method further comprising moving the sharp hub toretract the sharp into the housing when the needle shroud moves to theretracted position with a driver spring extending between the sharp huband the sensor retainer. Element 19: wherein the plurality of fingersare extendable into the sharp hub and interpose the needle shroud and aninner wall of the sharp hub when the needle shroud is in the extendedposition, the method further comprising moving the sharp hub to retractthe sharp into the housing when the needle shroud moves to the retractedposition with a driver spring extending between the sharp hub and thesensor retainer.

By way of non-limiting example, exemplary combinations applicable to Xand Y include: Element 1 with Element 2; Element 1 with Element 3;Element 3 with Element 4; Element 1 with Element 5; Element 1 withElement 6; Element 8 with Element 9; Element 9 with Element 10; Element8 with Element 11; Element 11 with Element 12; Element 11 with Element13; Element 15 with Element 16; Element 17 with Element 19; and Element17 with Element 19.

Localized Axial-Radial Sensor Seal for Analyte Monitoring

Referring briefly again to FIG. 1, the system 100 may comprise what isknown as a “two-piece” architecture that requires final assembly by auser before the sensor 110 can be properly delivered to the targetmonitoring location. According to embodiments of the present disclosure,the sensor control device assembly of FIG. 1 may instead comprise aone-piece architecture that incorporates sterilization techniquesspecifically designed for a one-piece architecture. The one-piecearchitecture allows the sensor control device assembly to be shipped tothe user in a single, sealed package that does not require any finaluser assembly steps. Rather, the user need only open one package andsubsequently deliver the sensor control device to the target monitoringlocation. The one-piece system architecture described herein may proveadvantageous in eliminating component parts, various fabrication processsteps, and user assembly steps. As a result, packaging and waste arereduced, and the potential for user error or contamination to the systemis mitigated.

FIGS. 81A and 81B are isometric and side views, respectively, of anexample sensor control device 8102. The sensor control device 8102 maybe similar in some respects to the sensor control device 104 of FIG. 1and therefore may be best understood with reference thereto. In someapplications, the sensor control device 8102 may replace the sensorcontrol device 104 of FIG. 1 and, therefore, may be used in conjunctionwith the analyte monitoring system 100 (FIG. 1) or the sensor applicator102, which delivers the sensor control device 8102 to a targetmonitoring location on a user's skin.

The sensor control device 8102 includes an electronics housing 8104 thatis generally disc-shaped and may have a circular cross-section. In otherembodiments, however, the electronics housing 8104 may exhibit othercross-sectional shapes, such as ovoid or polygonal and may benon-symmetrical. The electronics housing 8104 may include a shell 8106and a mount 8108 configured to engage or couple with the shell 8106. Theshell 8106 may be secured to the mount 8108 via a variety of ways, suchas a snap fit engagement, an interference fit, sonic (or ultrasonic)welding, using one or more mechanical fasteners (e.g., screws), or anycombination thereof. In some embodiments, the interface between theshell 8106 and the mount 8108 may be sealed. In such embodiments, agasket or other type of seal material may be positioned or applied at ornear the outer diameter (periphery) of the shell 8106 and the mount8108. Securing the shell 8106 to the mount 8108 may compress the sealmaterial and thereby generate a sealed interface. In at least oneembodiment, an adhesive may be applied to the outer diameter (periphery)of one or both of the shell 8106 and the mount 8108, and the adhesivemay not only secure the shell 8106 to the mount 8108 but may also sealthe interface.

In embodiments where a sealed interface is created between the shell8106 and the mount 8108, the interior of the electronics housing 8104may be effectively isolated from outside contamination between the twocomponents. In such embodiments, if the sensor control device 8102 isassembled in a controlled and sterile environment, there may be no needto sterilize the internal electrical components (e.g., via gaseouschemical sterilization). Rather, the sealed engagement may provide asufficient sterile barrier for the assembled electronics housing 8104.

The sensor control device 8102 may further include a sensor 8110, asharp module 8112 engaged with the sensor 8110. The sensor 8110 and thesharp module 8112 may be interconnectable and may be coupled to theelectronics housing 8104. The sharp module 8112 may be configured tocarry and otherwise include a sharp 8116 used to help deliver the sensor8110 transcutaneously under a user's skin during application of thesensor control device 8102.

As best seen in FIG. 81B, corresponding portions of the sensor 8110 andthe sharp 8116 extend from the electronics housing 8104 and, moreparticularly, from the bottom of the mount 8108. The exposed portion ofthe sensor 8110 may be received within a hollow or recessed portion ofthe sharp 8116. The remaining portion(s) of the sensor 8110 is/arepositioned within the interior of the electronics housing 8104.

FIG. 82 is an exploded perspective top view of the sensor control device8102, according to one or more embodiments. As illustrated, the shell8106 and the mount 8108 of the electronics housing 8104 may operate asopposing clamshell halves that enclose or otherwise substantiallyencapsulate the various electronic components of the sensor controldevice 8102. Various electrical components may be positioned within theelectronics housing 8104, including a printed circuit board (PCB) 8202having a plurality of electronic modules 8204 and a battery 8205 mountedto the PCB 8202. The battery 8205 may be configured to power the sensorcontrol device 8102. Example electronic modules 8204 include, but arenot limited to, resistors, transistors, capacitors, inductors, diodes,integrated circuits, and switches. A data processing unit 8206 (FIG. 82)may also be mounted to the PCB 8202 and may comprise, for example, anapplication specific integrated circuit (ASIC) configured to implementone or more functions or routines associated with operation of thesensor control device 8102. More specifically, the data processing unit8206 may be configured to perform data processing functions, such asfiltering and encoding of data signals, each of which corresponds to asampled analyte level of the user. The data processing unit 8206 mayalso include or otherwise communicate with an antenna for communicatingwith the reader device 106 (FIG. 1). As shown in FIG. 82, the PCB 8202and various components mounted to it may be encapsulated or otherwisecontained within an encapsulating material 8207.

As illustrated in FIG. 82, the shell 8106, the mount 8108, and the PCB8202, and encapsulating material 8207 each define corresponding channelsor apertures 8208 a, 8208 b, 8208 c, 8208 d, respectively. Due to theirplacement with respect to the outer surface of electronics housing 8104,aperture 8208 a in the shell 8106 may be referred to as a top aperture,and aperture 8208 b in the mount 8108 may be referred to as a bottomaperture. The mount 8108 further includes a channel 8210 that extendsupward from aperture 8208 b and a slot 8212 that extends through a sidewall of channel 8210. When the sensor control device 8102 is assembled,the apertures 8208 a-c align and the channel 8210 extends throughapertures 8208 a, 8208 c, 8208 d to receive portions of the sensor 8110and the sharp module 8112 therethrough. The centers or central regionsof apertures 8208 a, 8208 b, 8208 c, 8208 d and channel 8210 arearranged in an eccentric manner with respect to electronics housing8104, being spaced apart from the sensor central axis 8105. The sharp8110 and sensor 8110, which may extend through at least one of theseapertures and channel 8210, are likewise spaced apart from the sensorcentral axis 8105 and are arranged in an eccentric manner.

The sensor control device 8102 may further include a housing support8250 to be located in electronics housing 8104 in the vicinity ofapertures 8208 a, 8208 b, 8208 c, 8208 d to provide support betweenshell 8106 and mount 8108. The illustrated embodiment, housing support8250 for electronics housing 8104 is a collar 8250. The collar 8250 mayexhibit a variety of shapes, such as cylindrical, tubular, annular,polygonal, or any combination thereof.

The sensor 8110 includes a tail 8216, a flag 8218, and a neck 8220 thatinterconnects the tail 8216 and the flag 8218. The central aperture 8208b and channel 8210 defined in the mount 8108 may be configured toreceive the tail 8216, which may extend therethrough and extend distallyfrom the underside thereof. The slot 8212 in the mount 8108 may beconfigured to receive the sensor neck 8220, allowing the flag 8218 toextend to or toward the PCB 8202. The tail 8216 includes an enzyme orother chemistry or biologic and, in some embodiments, a membrane maycover the chemistry. In use, the tail 8216 is transcutaneously receivedbeneath a user's skin, and the chemistry included thereon helpsfacilitate analyte monitoring in the presence of bodily fluids.

The flag 8218 may comprise a generally planar surface having one or moresensor contacts 8222 (two shown in FIG. 82) disposed thereon. The flag8218 or the contacts 8222 are configured to couple electrically to thePCB 8202 or modules on PCB 8202, which may include a correspondingnumber of contacts (not shown), such as contacts on compliant carbonimpregnated polymer modules for example.

The sharp module 8112 includes the sharp 8116 and a sharp hub 8230 thatcarries the sharp 8116. The sharp 8116 includes an elongate shaft 8232and a sharp tip 8234 at the distal end of the shaft 8232. The shaft 8232may be configured to extend through each of the coaxially alignedcentral apertures 8208 a-c and extend distally from the bottom of themount 8108. Moreover, the shaft 8232 may include a hollow or recessedportion 8236 that at least partially circumscribes the tail 8216 of thesensor 8110. The sharp tip 8234 may be configured to penetrate the skinwhile carrying the tail 8216 to put the active chemistry of the tail8216 into contact with bodily fluids.

The sharp hub 8230 may include a hub small cylinder 8238 and a hub snappawl 8240, each of which may be configured to help couple the sensorcontrol device 8102 to the sensor applicator 102 (FIG. 1).

An adhesive or adhesive patch (not shown), similar to the adhesive patch108 of FIG. 1, may be positioned on and otherwise attached to the bottom8111 of the mount 8108. As discussed above, the adhesive patch may beconfigured to secure and maintain the sensor control device 8102 inposition on the user's skin during operation.

FIG. 83 is a cross-sectional side view of a sensor control deviceassembly 8310 having a central or longitudinal assembly axis 8311 andincluding a sensor applicator 8312 with a cap 8330 coupled thereto andthe sensor control device 8102 installed inside. In some applications,the sensor control device assembly 8310 with its sensor control device8102 and applicator 8312 may replace the sensor control device 104 andthe applicator 102 of FIG. 1 and, therefore, may be used in conjunctionwith the analyte monitoring system 100 (FIG. 1).

The cap 8330 may be threaded to the sensor applicator 8312 and mayinclude a tamper-evident ring or wrap (not shown) to evidence or inhibitpremature unthreading. Moreover, the cap 8330 may define an undercut8313 at the base of the threaded interface that provides additionalstiffness in tilting at the interface between the cap 8330 and thehousing 8314 and a detent force that may need to be overcome for the cap8330 to unscrew. Upon rotating (e.g., unscrewing) the cap 8330 relativeto sensor applicator 8312, the tamper ring or wrap may shear and therebyfree the cap 8330 and desiccant 8315 from the sensor applicator 8312.Following which, the user may deliver the sensor control device 8102 tothe target monitoring location.

The sensor applicator 8312 includes a housing 8314 that is disposedaround and slidingly coupled to a sheath 8318 and is configured to movea prescribed axial distance relative to the sheath 8318. Sheath 8318defines a bottom for sensor applicator 8312, the bottom that restsagainst a user's skin, for example, when sensor control device assembly8310 is used to place a sensor control device 8102 on the user. Sensorapplicator 8312 also includes a sharp carrier 8360 and a sensor carrier8364 interposed between the sheath 8318 and sharp carrier 8360. Sensorcarrier 8364 includes a radially extending platform 8366 located belowsharp carrier 8360, which may rest on the platform 8366. Platform 8366is coupled to housing 8314 to move when housing 8314 moves axiallyrelative to sheath 8318.

The cap 8330 may include an outer shell 8332 that extends from athreaded first end 8333 to a bottom or second end 8334. A base 8336 maybe located at the second end 8334, a support structure 8338 may extendfrom the base 8336 upward toward the first end 8333, and a post 8350extending from the support structure 8338. Likewise, when installed,support structure 8338 may extend upward from the bottom of the sheath8318 of the sensor applicator 8312. The support structure 8338 islocated within the outer shell 8332 and includes an inner shell 8340supported by a plurality of ribs 8342. Viewed from base 8336, innershell 8340 is concave. The post 8350 is centrally located within theinterior of the cap 8330 and may be aligned with assembly axis 8311. Thepost 8350 extends downward from a first end 8353 at the top of innershell 8340 to a second end 8354 closer to cap base 8336. The post 8350defines a post chamber 8356, which is open at first end 8353 and closedat second end 8354.

The support structure 8338 or the post 8350 may be configured to helpsupport the sensor control device 8102 while contained within the sensorapplicator 8312. Moreover, the post chamber 8356 is configured toreceive the sensor 8110 and the sharp 8116 when extending from thebottom of the electronics housing 8104. When the sensor control device8102 is loaded into the sensor applicator 8312, the sensor 8110 and thesharp 8116 may be arranged within a sealed region 8370 at leastpartially defined by the post chamber 8356 and configured to isolate thesensor 8110 and the sharp 8116 from various other regions in sensorcontrol device assembly 8310, which may contain various fluids orcontaminants at various times.

The cap 8330 provides a barrier against outside contamination, andthereby maintains a sterile environment for the sensor control deviceassembly 8310, including the sensor control device 8102 containedtherein, until the user removes (unthreads) the cap 8330. The cap 8330may also create a dust-free environment during shipping and storage.

A desiccant 8315 may be included in cap 8330, being located within theouter volume of the inner shell 8340, and a cover member or seal 8316,which in this example includes foil, may be applied to base 8336 tocontain and seal the desiccant 8315 against the intrusion of moistureand other contamination, and may also provide evidence of tampering.

In some embodiments, the seal 8316 may comprise only a single protectivelayer applied to the cap 8330, such as foil. In some embodiments, theseal 8316 may comprise two or more layers of different materials. Thefirst layer may be made of a synthetic material (e.g., a flash-spunhigh-density polyethylene fiber), such as Tyvek® available from DuPont®.Tyvek® is highly durable and puncture resistant and allows thepermeation of vapors. The Tyvek® layer can be applied before a gaseouschemical sterilization is performed, and following the gaseous chemicalsterilization, a foil or other vapor and moisture resistant materiallayer may be sealed (e.g., heat sealed) over the Tyvek® layer to preventthe ingress of contaminants and moisture.

Referring now to FIG. 84, illustrated is an enlarged cross-sectionalside view of the sensor control device assembly 8310 having sensorcontrol device 8102 mounted within the sensor applicator 8312 and thecap 8330 secured thereto, according to one or more embodiments. Thesensor control device 8102 may be loaded into the sensor applicator 8312by mating the sharp hub 8230 with the sharp carrier 8360 and by matingthe electronics housing 8104 of the sensor control device 8102 with thesensor carrier 8364 (alternately referred to as a “puck carrier”). Morespecifically, the hub small cylinder 8238 and the hub snap pawl 8240 ofsharp hub 8230 may be received by corresponding mating features of thesharp carrier 8360.

After installation in sensor control device assembly 8310, the sensorcontrol device 8102 may be subjected to “focused” radiationsterilization 8404, where the radiation is applied and otherwisedirected toward the sensor 8110 and the sharp 8116. In such embodiments,some or all of the electrical components 8204 (FIG. 82), such ascomponents group 8406 indicated with a dashed enclosure in FIG. 84, maybe positioned out of the range (span) of the propagating radiation 8404and, therefore, will not be affected by the radiation. For this purpose,apertures 8208 a, 8208 b, 8208 c, 8208 d, sensor 8110, and sharp module8112 are spaced apart from the sensor central axis 8105 to increase thedistance between these features that receive radiation 8404 and thecomponents group 8406 of PCB 8202 that may contain various of thecomponents 8204, 8206 that are to be protected from radiation 8404. Forexample, some or all of the electrical components 8204 and the dataprocessing unit 8206, as examples, may be positioned on the PCB 8202near its outer periphery so as not to fall within the range (span) ofthe focused radiation sterilization 8404. In other embodiments, thisprotection from radiation may be accomplished by shielding some or allof the electrical components 8204 and the data processing unit 8206, asexamples, with proper electromagnetic shields.

As indicated above, portions of the sensor 8110 and the sharp 8116 maybe arranged within the sealed region 8370 and thereby protected fromsubstances that might adversely interact with the chemistry of thesensor 8110. More specifically, the sealed region 8370 protects the tail8216. The sealed region 8370 may include (encompass) select portions ofthe interior of the electronics housing 8104 and the post chamber 8356of the post 8350. In one or more embodiments, the sealed region 8370 maybe defined and otherwise formed by at least a first seal 8408 a and asecond seal 8408 b. Coupling the shell 8106 to the mount 8108 may createa sealed interface therebetween that may also participate in definingthe extent of sealed region 8370.

The first seal 8408 a may be arranged to seal an interface between thesharp hub 8230 and the shell 8106. In the present example, the firstseal 8408 a may be arranged to seal a first interface 8411 between thesensor carrier 8364 and the top of the electronics housing 8104, e.g.,the shell 8106. The first seal 8408 a may also be arranged to seal asecond interface 8412 between the sensor carrier 8364 and sharp hub 8230of the sharp module 8112. Moreover, at first interface 8411 the firstseal 8408 a may circumscribe the first central aperture 8208 a definedin the shell 8106 such that contaminants are prevented from migrating ina radial direction (relative to sensor axis 8105) into the interior ofthe electronics housing 8104 via the first central aperture 8208 a orchannel 8210. At second interface 8412 the first seal 8408 a may preventfluid from migrating in an axial direction relative to assembly axis8311 (or, alternatively, relative to sensor axis 8105) into the interiorof the electronics housing 8104 via the first central aperture 8208 a orchannel 8210. Therefore, the first seal 8408 a interposes the sensorcarrier 8364 and the electronics housing 8104 and interposes sensorcarrier 8364 and the sharp hub 1039 and is configured to provide axialand radial sealing. In this example, first seal 8408 a is interposedbetween sensor applicator 8312 (e.g., the sensor carrier 8364) andsensor control device 8104 and is also interposed between sensorapplicator 8312 and sharp module 8112.

In at least one embodiment, the first seal 8408 a may be overmolded onto the sensor carrier 8364, thus forming a part of sensor carrier 8364.In other embodiments, however, the first seal 8408 a may form part ofthe sharp hub 8230, such as by being overmolded onto the sharp hub 8230.In yet other embodiments, the first seal 8408 a may be overmolded ontothe top surface of the shell 8106. In even further embodiments, thefirst seal 8408 a may comprise a separate structure, such as an O-ringor the like, that interposes the sharp hub 8230 and the top surface ofthe shell 8106, without departing from the scope of the disclosure.

The second seal 8408 b may be arranged to seal an interface 8413 betweenthe post 8350 and the bottom of the mount 8108, and the second seal 8408b may circumscribe the second central aperture 8208 b defined in themount 8108. The second seal 8408 b may also circumscribe the postchamber 8356. Consequently, the second seal 8408 b may preventcontaminants from migrating into the post chamber 8356 of the post 8350and also from migrating into the interior of the electronics housing8104 via the second central aperture 8208 b. For clarity, interface 8413may also be referred to as a third interface. At third interface 8413,the second seal 8408 b may prevent fluid from migrating in the radialdirection.

As illustrated in FIG. 84, the housing support 8250, which in thisexample is a collar 8250, may be located in electronics housing 8104 inthe vicinity of apertures 8208 a, 8208 b, 8208 c, 8208 d and aroundcollar 8250 of mount 8108 to provide support between shell 8106 andmount 8108 when an axial force is applied to engage seals 8408 a, 8408 bwith electronics housing 8104. The collar 8250 extends between the topand bottom of the electronics housing 8104 (e.g. shell 8106 and mount8108, respectively) and is positioned about the sensor 8110 to supportthe top of the electronics housing 8104 against flexing toward thebottom of the electronics housing and to support the bottom of theelectronics housing against flexing toward the top of the electronicshousing. Thus, collar 8250 is configured to provide a reaction forcebetween top and bottom of the electronics housing 8104 when seals 8408a, 8408 b engage electronics housing 8104. Some embodiments include ahousing support 8250 that is formed or bonded as a portion ofelectronics housing 8104 and may be, as examples, an extension of shell8106 or an extension of mount 8108.

Upon loading the sensor control device 8102 into the sensor applicator8312 and securing the cap 8330 to the sensor applicator 8312, the firstand second seals 8408 a,b become compressed and generate correspondingsealed interfaces. The first and second seals 8408 a,b may be made of avariety of materials capable of generating a sealed interface betweenopposing structures. Suitable materials include, but are not limited to,silicone, a thermoplastic elastomer (TPE), polytetrafluoroethylene(Teflon®), rubber, an elastomer, or any combination thereof.

The cap 8330 may be secured to the sensor applicator 8312 by threadingthe cap 8330 to the sensor applicator 8312 via relative rotation. As thecap 8330 rotates relative to the sensor applicator 8312, the post 8350advances axially until post 8350 or the inner shell 8340 of cap 8330engages the second seal 8408 b on the sealable surface 8418 at thebottom of the mount 8108, creating a sealed interface 8413 therebetween.As the electronics housing 8104 of sensor control device 8102 is urgedto rotate through frictional engagement between the second seal 8408 band post 8350 or the inner shell 8340 of cap 8330, sensor carrier 8364inhibits rotation of the sensor control device 8102.

FIG. 85 shows a bottom view of sensor control device 8102 and sensorcarrier 8364. Sensor carrier 8364 includes a pair of arms 8506 thatextend around sensor control device 8102. Arms 8506 may grasp notchesformed in electronic housing 8106. As illustrated, a sealable surface8418 that extends around second central aperture 8208 b may be definedon the bottom of the mount 8108. The sealable surface 8418 may comprisea groove. The sealable surface 8418 may receive second seal 8408 b toisolate (protect) the tail 8216 of the sensor 8110 from environmentalcontamination or from potentially harmful sterilization gases whengaseous chemical sterilization is used. In the illustrated embodiment,the second seal 8408 b is overmolded onto the bottom of the mount 8108within a groove of sealable surface 8418. Thus, second seal 8408 b formsa part of the electronics housing 8104. In other embodiments, however,the second seal 8408 b may form part of the post 8350 (FIG. 84). Forexample, the second seal 8408 b may be overmolded onto the top of thepost 8350. In yet other embodiments, the second seal 8408 b may comprisea separate structure, such as an O-ring or the like, that interposes thepost 8350 and the bottom of the mount 8108, without departing from thescope of the disclosure.

FIG. 86 is a schematic diagram of an example sterilization assembly8600, according to one or more embodiments of the present disclosure.The sterilization assembly 8600 (hereafter the “assembly 8600”) may bedesigned and otherwise configured to help sterilize a medical device8602 that may be deployed for use from a sensor applicator 8604. Themedical device 8602 may comprise, for example, a sensor control devicesimilar in some respects to any of the sensor control devices describedherein. In such embodiments, the sensor applicator 8604 may be similarin some respects to any of the sensor applicators described herein.Alternatively, the medical device 8602 may comprise other types ofmedical devices, health care products, or systems requiring terminalsterilization of specific component parts. Example medical devices orhealth care products that may incorporate the principles of the presentdisclosure include, but are not limited to, ingestible products, cardiacrhythm management (CRM) devices, under-skin sensing devices, externallymounted medical devices, or any combination thereof.

As illustrated, the medical device 8602 may include a housing 8606, apart 8608 requiring sterilization, and one or more radiation sensitivecomponents 8610. In the illustrated embodiment, the radiation sensitivecomponent 8610 may be mounted to a printed circuit board (PCB) 8612positioned within the housing 8606 and may include one or moreelectronic modules such as, but not limited to, a data processing unit(e.g., an application specific integrated circuit or ASIC), a resistor,a transistor, a capacitor, an inductor, a diode, and a switch.

As illustrated, the part 8608 may extend at an angle relative to thehousing 8606, but could alternatively extend perpendicular to thehousing 8606. In some embodiments, the part 8608 may comprise a sensor(e.g., the sensor 8110 of FIGS. 81A-81B) and a sharp (e.g., the sharp8116 of FIGS. 81A-81B) used to help implant the sensor beneath the skinof a user. In some embodiments, as illustrated, the part 8608 may betemporarily encapsulated within a sterile chamber 8614 that provides asealed barrier to protect exposed portions of the part 8608 (e.g., thesensor and associated sharp) until the part 8608 is needed for use.

The medical device 8602 may be subjected to radiation sterilization 8616to properly sterilize the part 8608 for use. Suitable radiationsterilization 8616 processes include, but are not limited to, electronbeam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, orany combination thereof. As illustrated, the assembly 8600 may include aradiation shield 8618 positioned external to the medical device 8602 andconfigured to help sterilize the part 8608 while preventing (impeding)propagating radiation 8616 from disrupting or damaging the radiationsensitive components 8610. To accomplish this, the radiation shield 8618may provide a collimator 8620 that generally comprises a hole orpassageway extending at least partially through the body of theradiation shield 8618. The collimator 8620 provides a sterilization zonedesigned to direct (focus) the radiation 8616 toward the part 8608.

While the collimator 8610 focuses the radiation 8616 (e.g., beams,waves, energy, etc.) toward the part 8608, the remaining portions of theradiation shield 8618 may be made of a material that reduces oreliminates the radiation 8616 from penetrating therethrough and therebydamaging the radiation sensitive components 8610 within the housing8606. In other words, the radiation shield 8618 may be made of amaterial having a density sufficient to absorb the dose of the beamenergy being delivered. In some embodiments, for example, the radiationshield 8618 may be made of any material that has a mass density greaterthan 0.9 grams per cubic centimeter (g/cc). In other embodiments,however, the mass density of a suitable material may be less than 0.9g/cc, without departing from the scope of the disclosure. Suitablematerials for the radiation shield 8618 include, but are not limited to,a high-density polymer, (e.g., polyethylene, polypropylene, polystyrene,polytetrafluoroethylene, etc.), a metal (e.g., lead, stainless steel,aluminum, etc.), any combination thereof, or any material having a massdensity greater than 0.9 g/cc.

The collimator 8620 can exhibit any suitable cross-sectional shapenecessary to focus the radiation on the part 8608 for sterilization. Inthe illustrated embodiment, for example, the collimator 8620 has acircular cross-section with parallel sides. In other embodiments,however, the collimator 8620 may have a polygonal cross-sectional shape,such as cubic or rectangular (e.g., including parallelogram), withoutdeparting from the scope of the disclosure.

In some embodiments, the assembly 8600 may further include a barriershield 8622 positioned within the housing 8606. The barrier shield 8622may be configured to help block radiation 8616 (e.g., electrons) frompropagating within the housing 8606 toward the radiation sensitivecomponents 8610. The barrier shield 8622 may be made of any of thematerials mentioned above for the radiation shield 8618. In theillustrated embodiment, the barrier shield 8622 is positioned verticallywithin the housing 8606, but may alternatively be positioned at anyother angular configuration suitable for protecting the radiationsensitive components 8610.

In some embodiments, the sterile chamber 8614 may comprise a cap thatencapsulates the part 8608 to provide a sealed barrier that protectsexposed portions of the part 8608 until the part 8608 is placed in use.In such embodiments, the sterile chamber 8614 may be removable ordetachable to expose the part 8608, as described below. Moreover, insuch embodiments, the cap may be made of a material that allowsradiation to propagate therethrough to allow sterilization of the part8608. Suitable materials for the sterile chamber 8614 include, but arenot limited to, a non-magnetic metal (e.g., aluminum, copper, gold,silver, etc.), a thermoplastic, ceramic, rubber (e.g., ebonite), acomposite material (e.g., fiberglass, carbon fiber reinforced polymer,etc.), an epoxy, or any combination thereof. In some embodiments, thesterile chamber 8614 may be transparent or translucent, but canotherwise be opaque, without departing from the scope of the disclosure.

In other embodiments, the sterile chamber 8614 may comprise a chamber orcompartment defined within one or both of the sensor applicator 8604 andthe sensor control device 8602. In such embodiments, the sterile chamber8614 may include a microbial barrier positioned at one or both ends ofthe sterile chamber 8614. More specifically, the sterile chamber 8614may provide or include an upper microbial barrier 8624 a and a lowermicrobial barrier 8624 b opposite the upper microbial barrier 8624 a.The upper and lower microbial barriers 8624 a,b may help seal thesterile chamber 8614 to thereby isolate the part 8608 from externalcontamination. The microbial barriers 8624 a,b may be made of aradiation permeable material, such as a synthetic material (e.g., aflash-spun high-density polyethylene fiber). One example syntheticmaterial comprises TYVEK®, available from DuPont®. In other embodiments,however, the microbial barriers 8624 a,b may comprise, but are notlimited to, tape, paper, film, foil, or any combination thereof.

In embodiments where the sterile chamber 8614 comprises a cap, thesterile chamber 8614 may be movable distally to help facilitate thesterilization process. More specifically, the sterile chamber 8614 maybe movable at least partially into the sterilization zone formed by thecollimator 8620. Once positioned within the sterilization zone, the part8608 may be subjected to the radiation 8616 to sterilize the part 8608for use. Once sterilization is done, the sterile chamber 8614 may beretracted proximally in preparation for firing the sensor control device8602. Distally advancing the sterile chamber 8614 may be accomplishedvia a variety of mechanical or electromechancial means. In someembodiments, for example, the sensor applicator 8604 may include aplunger 8626 configured to advance distally to push the sterile chamber8614 distally, and subsequently retract the sterile chamber 8614 oncethe sterilization process is complete.

The part 8608 itself may also be deployable and otherwise movablerelative to the sensor applicator 8604. More particularly, the part 8608may be advanced distally past the bottom of the electronics housing 8606to allow the part 8608 to be transcutaneously received beneath a user'sskin. In some embodiments, the plunger 8626 may be used to push the part8608 out of the sterile chamber 8614. In such embodiments, the plunger8626 may also be configured to attach to a portion of the part 8608(e.g., the sharp) and subsequently retract that portion of the part 8608while leaving another portion of the part 8608 (e.g., the sensor)extended. Moreover, in such embodiments, the plunger 8626 may beconfigured to penetrate the upper microbial barrier 8624 a and force thepart 8608 distally through the lower microbial barrier 8624 b.

In other embodiments, the part 8608 may be advanced distally out of thesterile chamber 8614 using a magnetic coupling. More specifically, thesensor applicator 8604 may include a driver magnet 8628 movable withinthe sensor applicator 8604 and magnetically coupled to a driven magnet8630 disposed on the part 8608, such as on an upper end of the sharp.The driver magnet 8628 may be configured to advance distally andsimultaneously push the part 8608 out of the sterile chamber 8614 asmagnetically coupled to the driven magnet 8630. In such embodiments,actuation of the magnetic coupling may force the part 8608 distallythrough the lower microbial barrier 8624 b. Once the sensor is properlyplaced, the driver magnet 8628 may be retracted proximally andsimultaneously retract the sharp in the same direction while leaving thesensor extended.

In embodiments where the sterile chamber 8614 comprises a cap, theplunger 8626 may also be operable to discharge or push the cap out ofthe sensor applicator 8604 to enable the part 8608 to be properlyreceived by the user. In such embodiments, a user may commence thefiring process by priming the sensor applicator 8604, which may causethe cap to be discharged or ejected from the sensor applicator 8604.Further actuation of the sensor applicator 8604 by the user may causethe part 8608 to be fully extended for subcutaneous implantation. Inother embodiments, however, the cap may be removed either autonomously(e.g., it falls off or breaks away) or the user may manually remove itby hand.

In some embodiments, the sensor applicator 8604 may further include anelectrical connector 8632 in electrical communication with theelectronics of the sensor control device 8602, such as the radiationsensitive component 8610. In at least one embodiment, the electricalconnector 8632 may comprise one or more elastic pins made of aconductive polymer (e.g., a carbon impregnated polymer) and configuredto facilitate electrical communication between the sensor and theradiation sensitive component 8610. In such embodiments, the sensor mayinclude one or more connectors 8634 alignable with the electricalconnector 8632 when the part 8608 is advanced distally, as describedabove. Moreover, in embodiments where the sterile chamber 8614 comprisesa cap, the electrical connector 8632 may be flexible to allow the cap topass by the electrical connector 8632 until the connectors 8634 alignwith the electrical connector 8632.

FIG. 87 is a schematic diagram of another example sterilization assembly8700, according to one or more embodiments of the present disclosure.The sterilization assembly 8700 (hereafter the “assembly 8700”) may besimilar in some respects to the assembly 8600 of FIG. 86 and thereforemay be best understood with reference thereto, where like numerals willrepresent like components not described again in detail. Similar to theassembly 8600, for example, the medical device 8602 may be arranged fordeployment within the sensor applicator 8604, and the part 8608requiring sterilization may be temporarily encapsulated within thesterile chamber 8614. Unlike the assembly 8600, however, the part 8608may be subjected to the radiation sterilization 8616 through the body ofthe sensor applicator 8604.

More specifically, the radiation sterilization 8616 may be directed tothe top of the sensor applicator 8604, which defines a collimator 8702that allows the radiation 8616 to impinge upon and sterilize the part8608. As illustrated, the collimator 8702 generally comprises a hole orpassageway extending through the body of the sensor applicator 8604. Thecollimator 8702 focuses (guides) the radiation 8616 toward the part 8608and can exhibit any suitable cross-sectional shape necessary to focusthe radiation 8616 on the part 8608 for sterilization. In theillustrated embodiment, for example, the collimator 8702 has a circularcross-section with parallel sides, but may alternatively exhibit apolygonal cross-sectional shape, such as cubic or rectangular (e.g.,including parallelogram), without departing from the scope of thedisclosure.

The sensor applicator 8604 may also act as a radiation shield that helpsprevent (impede) propagating radiation 8616 from disrupting or damagingthe radiation sensitive components 8610, except through the collimator8702. To accomplish this, the sensor applicator 8604 may be made of amaterial similar to the material of the radiation shield 8618 of FIG.86. In at least one embodiment, however, the radiation sterilization8616 may be emitted from a device or machine configured to focus and/oraim the radiation 8616 directly into the collimator 8702, and therebymitigating radiation 8616 exposure to adjacent portions of the sensorapplicator 8604.

In some embodiments, a seal 8704 may be arranged at the opening to thecollimator 8702 at the top of the sensor applicator 8604. The seal 8704may comprise a radiation permeable, microbial barrier, similar to themicrobial barriers 8624 a,b of FIG. 86. The seal 8704 may seal off thecollimator 8702, while simultaneously allowing the radiation 8616 topass therethrough to sterilize the part 8608.

In at least one embodiment, the position of the radiation sensitivecomponents 8610 may be moved away from the line of fire of the radiation8616. In other embodiments, the barrier shield 8622 may extend about atleast two sides of the radiation sensitive components 8610 to ensuresufficient blockage of the radiation 8616. In at least one embodiment,however, the barrier shield 8622 may fully encapsulate the radiationsensitive components 8610.

In one embodiment, the radiation sterilization 8616 may be directedtoward the part 8608 from the bottom of the sensor control device 8602and the bottom of the sensor applicator 8604. In such embodiments, ashield 8706 may be positioned at the bottom of one or both of the sensorcontrol device 8602 and the bottom of the sensor applicator 8604. Theshield 8706 may be made of any of the materials mentioned above for theradiation shield 8618 of FIG. 86. Consequently, the shield 8706 may beconfigured to help block the radiation 8616 (e.g., electrons) frompropagating toward the radiation sensitive components 8610. The shield8706, however, may define or otherwise provide an aperture 8708 alignedwith the part 8608 to allow the radiation 8616 to impinge upon the part8608 for proper sterilization.

In at least one embodiment, the shield 8706 may form part of the sensorcontrol device 8602 and may be deployed simultaneously with the sensorcontrol device 8602 from the sensor applicator 8604. In someembodiments, the shield 8706 may be removable from the sensor controldevice 8602 and otherwise only used during the sterilization process. Inother embodiments, the shield 8706 may be arranged within the housing8606 and otherwise form an integral part thereof, without departing fromthe scope of the disclosure.

FIG. 88A is a schematic bottom view of another example sterilizationassembly 8800, according to one or more embodiments of the presentdisclosure. The sterilization assembly 8800 (hereafter the “assembly8800”) may be used to sterilize a medical device 8802, which maycomprise a sensor control device or any of the other types of medicaldevices mentioned herein. In the illustrated embodiment, the medicaldevice 8802 comprises a sensor control device having a housing 8804 thatdefines an aperture 8806 through which a part 8808 requiringsterilization may extend. In the view of FIG. 88A, the part 8808 extendsthrough the aperture 8806 and out of the page. Moreover, the part 8808may comprise one or both of a sensor and a sharp, as generally describedherein. The medical device 8802 may also include a battery 8810 and aradiation sensitive component 8812 arranged within the housing 8804. Thebattery 8810 may power the medical device 8802 and the radiationsensitive component 8812 may be similar to the radiation sensitivecomponent 8610 of FIGS. 86 and 87.

As illustrated, the housing 8804 may exhibit a generally polygonalcross-sectional shape. More specifically, the housing 8804 is generallytriangular with rounded corners. The position of the radiation sensitivecomponent 8812 relative to the part 8808 is effectively as far away aspossible within the confines of the housing 8804. As will beappreciated, this may help reduce the chances of the radiation sensitivecomponent 8812 being damaged during a radiation sterilization process tosterilize the part 8808.

The assembly 8800 may also include a shield 8814 (shown in dashedlines), which may be made of the materials mentioned above for theradiation shield 8618 of FIG. 86. Consequently, the shield 8814 may beconfigured to help protect the radiation sensitive component 8812 fromdamaging radiation during a sterilization process. In one embodiment,the shield 8814 may be arranged external to the housing 8804 andotherwise arranged to interpose the radiation sensitive component 8812and the propagating electrons from the radiation treatment. In otherembodiments, however, the shield 8814 may be arranged within the housing8804 and otherwise form part of the medical device 8802, withoutdeparting from the scope of the disclosure.

FIGS. 88B and 88C are schematic bottom views of alternative embodimentsof the sterilization assembly 8800 of FIG. 88A, according to one or moreadditional embodiments of the present disclosure. In FIG. 88B, thehousing 8804 exhibits a generally circular shape, and in FIG. 88C, thehousing 8804 exhibits a generally oval or ovoid shape. As will beappreciated, the housing 8804 may alternatively exhibit othercross-sectional shapes, including additional polygonal shapes (e.g.,square, rectangular, pentagonal, etc.), without departing from the scopeof the disclosure.

In FIGS. 88B and 88C, the part 8808 extends through the aperture 8806and out of the page. Moreover, the battery 8810 and the radiationsensitive component 8812 may be arranged within the housing 8804 and theradiation sensitive component 8812 may be positioned relative to thepart 8808 as far away as possible within the confines of the housing8804. Again, this may help reduce the chances of the radiation sensitivecomponent 8812 being damaged during a radiation sterilization process tosterilize the part 8808. The shield 8814 (shown in dashed lines) mayagain be included and configured to help protect the radiation sensitivecomponent 8812 from damaging radiation during a sterilization process.As illustrated, the shield 8814 may be arranged external to the housing8804, or alternatively within the housing 8804 and otherwise form partof the medical device 8802, without departing from the scope of thedisclosure.

FIG. 89 is an isometric schematic view of an example sensor controldevice 8900, according to one or more embodiments. The sensor controldevice 8900 may be similar in some respects to the sensor controldevices described herein and, therefore, may be used as an on-bodymonitoring device used to monitor blood glucose levels. As illustrated,the sensor control device 8900 includes a housing 8902 that may containand otherwise housing electronics used to operate the sensor controldevice 8900. In the illustrated embodiment, the housing 8902 isgenerally disc-shaped and with a circular cross-section, but couldalternatively exhibit other cross-sectional shapes, such as ovoid orpolygonal and may be non-symmetrical. While not shown, an adhesive patchmay be attached to the bottom of the housing 8902 to help attach thesensor control device 8900 to the skin of a user at a target monitoringlocation.

The sensor control device 8900 may further include a sensor 8904 and asharp 8906 extending distally from the bottom of the housing 8902. Thesensor 8904 and the sharp 8906 may be similar in some respects to thesensor 8110 and the sharp 8116 of FIGS. 81A-81B. Accordingly, in someembodiments, the sharp 8906 may be used to help deliver the sensor 8904transcutaneously under a user's skin during application of the sensorcontrol device 8900. The exposed portion of the sensor 8904 may bereceived within a hollow or recessed portion of the sharp 8906, and theremaining portion(s) of the sensor 8904 is/are positioned within theinterior of the electronics housing 8902.

In some embodiments, the sharp 8906 may be made of a dermal-dissolvingmaterial. In such embodiments, the sharp 8906 may be used to helpintroduce the sensor 8904 into the user's skin, but may dissolve after apredetermined time period upon exposure to chemicals and/or substancescommonly found in the human body. Consequently, in such embodiments,there is no need to retract the sharp 8906. Rather, the sharp 8906 mayremain embedded within the user's dermal layer until it safelydissolves. A dermal-dissolving sharp 8906 may also make sterilizationapplications much easier, since low-energy surface sterilization mayonly be needed.

In other embodiments, the sharp 8906 may be omitted from the sensorcontrol device 8900. In such embodiments, the sensor 8904 may be made ofmaterials that are rigid enough to allow the sensor 8904 to betranscutaneously received beneath a user's skin for monitoring withoutthe assistance of the sharp 8906. Accordingly, the sensor 8906 mayoperate as both a sensor and a sharp or introducer. Such embodiments mayprove advantageous in eliminating the mechanisms and assembliestypically required to retract the sharp 8906.

As will be appreciated, any of the embodiments mentioned herein mayincorporate a dermal dissolving sharp or introducer, or mayalternatively include a sharp that operates as both a sensor and asharp, without departing from the scope of the disclosure.

FIG. 90 is a schematic diagram of another example sterilization assembly9000, according to one or more embodiments. Similar to the othersterilization assemblies described herein, the sterilization assembly9000 (hereafter the “assembly 9000”) may be used to help sterilize amedical device, such as a sensor control device 9002. The sensor controldevice 9002 may be similar in some respects to some or all of the sensorcontrol devices described herein. For example, the sensor control device9002 includes a housing 9004 that may contain and otherwise house theelectronics used to operate the sensor control device 9002. The sensorcontrol device 9002 may further include a part 9005 requiringsterilization, one or more radiation sensitive components 9006, and abattery 9008 that powers the sensor control device 9002. The radiationsensitive component 9006 may be arranged within the housing 9004 and mayinclude one or more electronic modules such as, but not limited to, adata processing unit (e.g., an application specific integrated circuitor ASIC), a resistor, a transistor, a capacitor, an inductor, a diode,and a switch.

As illustrated, the part 9005 may extend perpendicularly from the bottomof the housing 9004, but could alternatively extend at an angle relativeto the housing 9004. Moreover, while the part 9005 extends generallyconcentric with a centerline of the housing 9004, the part 9005 couldalternatively extend from the housing 9004 at a location eccentric tothe centerline, without departing from the scope of the disclosure. Insome embodiments, the part 9005 may comprise a sensor (e.g., the sensor8110 of FIGS. 81A-81B) and a sharp (e.g., the sharp 8116 of FIGS.81A-81B) used to help implant the sensor beneath the skin of a user.

The medical device 8602 may be subjected to radiation sterilization 9010to properly sterilize the part 9005 for use. Suitable radiationsterilization 9010 processes include, but are not limited to, electronbeam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, orany combination thereof. To help guide and otherwise focus the radiation9010 toward the part 9005 and simultaneously away from the radiationsensitive component 9006, the assembly 9000 may include or otherwiseemploy one or more magnets configured to direct the electrons of theradiation 9010 in a predetermined sterilization path.

More particularly, as illustrated, the assembly 9000 may include acentral magnet 9012 and opposing lateral magnets 9014 a and 9014 b. Thecentral magnet 9012 may be arranged opposite a radiation source 9016such that the part 9005 to be sterilized interposes the central magnet9012 and the radiation source 9016. The central magnet 9012 may be tunedand otherwise configured to draw the electrons of the radiation 9010toward the central magnet 9012, which generally urges the radiation 9010toward the center of the sensor control device 9002 and otherwise towhere the part 9005 is located. In addition, the lateral magnets 9014a,b may be arranged on opposite sides of the sensor control device 9002and tuned or otherwise configured to generate a magnetic field thatpushes the electrons of the radiation 9010 toward the center of thesensor control device 9002 or otherwise to where the part 9005 islocated. Accordingly, the central and lateral magnets 9012, 9014 a,b maycooperatively urge the radiation 9010 away from the radiation sensitivecomponents 9006 and instead toward the part 9005 to sterilize the part9005.

Embodiments disclosed herein include:

Z. A sensor control device assembly that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing, a sensor extending from a bottom ofthe electronics housing, a sharp hub positioned adjacent a top of theelectronics housing, and a sharp carried by the sharp hub and extendingthrough the electronics housing and from the bottom of the electronicshousing, a cap removably coupled to the sensor applicator and providinga support structure that defines a post chamber that receives the sensorand the sharp extending from the bottom of the electronics housing, afirst seal that provides a radial seal against the sharp hub and anaxial seal against the top of the electronics housing, and a second sealthat seals an interface between the post and the bottom of theelectronics housing.

AA. A method including positioning a sensor control device within asensor applicator, the sensor control device including an electronicshousing, a sensor extending from a bottom of the electronics housing, asharp hub positioned adjacent a top of the electronics housing, and asharp carried by the sharp hub and extending through the electronicshousing and from the bottom of the electronics housing, removablycoupling a cap to the sensor applicator, the cap providing a supportstructure that defines a post chamber that receives the sensor and thesharp extending from the bottom of the electronics housing, providing aradial seal against the sharp hub with a first seal, providing an axialseal against the top of the electronics housing with the first seal, andsealing an interface between the post and the bottom of the electronicshousing with a second seal.

BB. A sensor control device assembly includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing having a top and a bottom, a sensorcoupled to the electronics housing, and a sharp module engageable withthe electronics housing and having a sharp. The sensor control deviceassembly further includes a post having a first end positioned proximalthe bottom of the electronics housing, a second end opposite the firstend, and a post chamber extending between the first and second ends,wherein distal portions of the sensor and the sharp are receivablewithin the post chamber, a first seal interposing the sensor applicatorand the electronics housing to seal an interface therebetween andinterposing the sensor applicator and the sharp module to seal aninterface therebetween, and a second seal interposing the first end ofthe post and the bottom of the electronics housing.

Each of embodiments Z, AA, and BB may have one or more of the followingadditional elements in any combination: Element 1: further comprising asensor carrier arranged within the sensor applicator to secure thesensor control device, wherein the first seal is overmolded onto thesensor carrier. Element 2: wherein the cap comprises a first endthreaded to the sensor applicator, and a second end opposite the firstend, and wherein the support structure extends from the second end intothe sensor applicator and toward the sensor control device. Element 3:wherein the first seal circumscribes a top aperture defined in theelectronics housing and prevents contaminants from migrating into aninterior of the electronics housing via the top aperture. Element 4:wherein the second seal circumscribes a bottom aperture defined on thebottom of the electronics housing and prevents contaminants frommigrating into an interior of the electronics housing via the bottomaperture and into the post chamber. Element 5: wherein the sensorcontrol device includes a housing support positioned within theelectronics housing and extending between the top and bottom of theelectronics housing and positioned about the sensor to support the topof the electronics housing against flexing toward the bottom of theelectronics housing and to support the bottom of the electronics housingagainst flexing toward the top of the electronics housing. Element 7:wherein the sensor and the sharp are positioned eccentric from a centralaxis of the electronics housing. Element 8: wherein the first seal isovermolded onto the top of the electronics housing.

Element 9: further creating a sealed region as the cap is coupled to thesensor applicator, the sealed region encompassing the post chamber and aportion of an interior of the electronics housing, wherein portions ofthe sensor and the sharp reside within the sealed region. Element 10:further comprising sterilizing the sensor and the sharp with radiationsterilization while positioned within the sensor applicator. Element 11:wherein the radiation sterilization is at least one of focused radiationsterilization and low-energy radiation sterilization. Element 12:wherein the first seal is over overmolded onto a sensor carrier arrangedwithin the sensor applicator to secure the sensor control device.Element 13: wherein removably coupling the cap to the sensor applicatorcomprises advancing the support structure into the sensor applicator andthereby causing the second seal to seal the interface between the postand the bottom of the electronics housing. Element 14: wherein thesensor control device includes a housing support positioned within theelectronics housing and extending between the top and bottom of theelectronics housing, the method further comprising supporting the top ofthe electronics housing against flexing toward the bottom of theelectronics housing with the housing support, and supporting the bottomof the electronics housing against flexing toward the top of theelectronics housing with the housing support. Element 15: furthercomprising preventing contaminants from migrating into an interior ofthe electronics housing via a top aperture defined in the electronicshousing with the first seal. Element 16: further comprising preventingcontaminants from migrating into the post chamber and an interior of theelectronics housing via a bottom aperture defined on the bottom of theelectronics housing with the second seal.

Element 17: further comprising a sensor carrier positioned within thesensor applicator to secure the sensor control device, wherein the firstseal seals a first interface between the sensor carrier and theelectronics housing and a second interface between the sensor carrierand the sharp module. Element 18: further comprising a cap removablycoupled to the sensor applicator and providing a support structure thatextends from the bottom of the sensor applicator toward the sensorcontrol device, wherein the post extends from the support structure.

By way of non-limiting example, exemplary combinations applicable to Z,AA, and BB include: Element 10 with Element 11; and Element 13 withElement 14.

Seal Arrangement for Analyte Monitoring Systems

FIGS. 91A and 91B are side and isometric views, respectively, of anexample sensor control device 9102, according to one or more embodimentsof the present disclosure. The sensor control device 9102 may be similarin some respects to the sensor control device 104 of FIG. 1 andtherefore may be best understood with reference thereto. Moreover, thesensor control device 9102 may replace the sensor control device 104 ofFIG. 1 and, therefore, may be used in conjunction with the sensorapplicator 102 of FIG. 1, which may deliver the sensor control device9102 to a target monitoring location on a user's skin.

As illustrated, the sensor control device 9102 includes an electronicshousing 9104, which may be generally disc-shaped and have a circularcross-section. In other embodiments, however, the electronics housing9104 may exhibit other cross-sectional shapes, such as ovoid, oval, orpolygonal, without departing from the scope of the disclosure. Theelectronics housing 9104 includes a shell 9106 and a mount 9108 that ismatable with the shell 9106. The shell 9106 may be secured to the mount9108 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, laser welding, one or more mechanicalfasteners (e.g., screws), a gasket, an adhesive, or any combinationthereof. In some cases, the shell 9106 may be secured to the mount 9108such that a sealed interface is generated therebetween. An adhesivepatch 9110 may be positioned on and otherwise attached to the undersideof the mount 9108. Similar to the adhesive patch 108 of FIG. 1, theadhesive patch 9110 may be configured to secure and maintain the sensorcontrol device 9102 in position on the user's skin during operation.

The sensor control device 9102 may further include a sensor 9112 and asharp 9114 used to help deliver the sensor 9112 transcutaneously under auser's skin during application of the sensor control device 9102.Corresponding portions of the sensor 9112 and the sharp 9114 extenddistally from the bottom of the electronics housing 9104 (e.g., themount 9108). A sharp hub 9116 may be overmolded onto the sharp 9114 andconfigured to secure and carry the sharp 9114. As best seen in FIG. 91A,the sharp hub 9116 may include or otherwise define a mating member 9118.In assembling the sharp 9114 to the sensor control device 9102, thesharp 9114 may be advanced axially through the electronics housing 9104until the sharp hub 9116 engages an upper surface of the electronicshousing 9104 or an internal component thereof and the mating member 9118extends distally from the bottom of the mount 9108. As described hereinbelow, in at least one embodiment, the sharp hub 9116 may sealinglyengage an upper portion of a seal overmolded onto the mount 9108. As thesharp 9114 penetrates the electronics housing 9104, the exposed portionof the sensor 9112 may be received within a hollow or recessed (arcuate)portion of the sharp 9114. The remaining portion of the sensor 9112 isarranged within the interior of the electronics housing 9104.

The sensor control device 9102 may further include a sensor cap 9120,shown detached from the electronics housing 9104 in FIGS. 91A-91B. Thesensor cap 9120 may help provide a sealed barrier that surrounds andprotects exposed portions of the sensor 9112 and the sharp 9114. Asillustrated, the sensor cap 9120 may comprise a generally cylindricalbody having a first end 9122 a and a second end 9122 b opposite thefirst end 9122 a. The first end 9122 a may be open to provide accessinto an inner chamber 9124 defined within the body. In contrast, thesecond end 9122 b may be closed and may provide or otherwise define anengagement feature 9126. As described in more detail below, theengagement feature 9126 may help mate the sensor cap 9120 to anapplicator cap of a sensor applicator (e.g., the sensor applicator 102of FIG. 1), and may help remove the sensor cap 9120 from the sensorcontrol device 9102 upon removing the sensor cap from the sensorapplicator.

The sensor cap 9120 may be removably coupled to the electronics housing9104 at or near the bottom of the mount 9108. More specifically, thesensor cap 9120 may be removably coupled to the mating member 9118,which extends distally from the bottom of the mount 9108. In at leastone embodiment, for example, the mating member 9118 may define a set ofexternal threads 9128 a (FIG. 91A) matable with a set of internalthreads 9128 b (FIG. 91B) defined within the inner chamber 9124 of thesensor cap 9120. In some embodiments, the external and internal threads9128 a,b may comprise a flat thread design (e.g., lack of helicalcurvature), but may alternatively comprise a helical threadedengagement. Accordingly, in at least one embodiment, the sensor cap 9120may be threadably coupled to the sensor control device 9102 at themating member 9118 of the sharp hub 9116. In other embodiments, thesensor cap 9120 may be removably coupled to the mating member 9118 viaother types of engagements including, but not limited to, aninterference or friction fit, or a frangible member or substance (e.g.,wax, an adhesive, etc.) that may be broken with minimal separation force(e.g., axial or rotational force).

In some embodiments, the sensor cap 9120 may comprise a monolithic(singular) structure extending between the first and second ends 9122a,b. In other embodiments, however, the sensor cap 9120 may comprise twoor more component parts. In the illustrated embodiment, for example, thebody of the sensor cap 9120 may include a desiccant cap 9130 arranged atthe second end 9122 b. The desiccant cap 9130 may house or comprise adesiccant to help maintain preferred humidity levels within the innerchamber 9124. Moreover, the desiccant cap 9130 may also define orotherwise provide the engagement feature 9126 of the sensor cap 9120. Inat least one embodiment, the desiccant cap 9130 may comprise anelastomeric plug inserted into the bottom end of the sensor cap 9120.

FIGS. 92A and 92B are exploded, isometric top and bottom views,respectively, of the sensor control device 9102, according to one ormore embodiments. The shell 9106 and the mount 9108 operate as opposingclamshell halves that enclose or otherwise substantially encapsulatevarious electronic components (not shown) of the sensor control device9102. Example electronic components that may be arranged between theshell 9106 and the mount 9108 include, but are not limited to, abattery, resistors, transistors, capacitors, inductors, diodes, andswitches.

The shell 9106 may define a first aperture 9202 a and the mount 9108 maydefine a second aperture 9202 b, and the apertures 9202 a,b may alignwhen the shell 9106 is properly mounted to the mount 9108. As best seenin FIG. 92A, the mount 9108 may provide or otherwise define a pedestal9204 that protrudes from the inner surface of the mount 9108 at thesecond aperture 9202 b. The pedestal 9204 may define at least a portionof the second aperture 9202 b. Moreover, a channel 9206 may be definedon the inner surface of the mount 9108 and may circumscribe the pedestal9202. In the illustrated embodiment, the channel 9206 is circular inshape, but could alternatively be another shape, such as oval, ovoid, orpolygonal.

The mount 9108 may comprise a molded part made of a rigid material, suchas plastic or metal. In some embodiments, a seal 9208 may be overmoldedonto the mount 9108 and may be made of an elastomer, rubber, a-polymer,or another pliable material suitable for facilitating a sealedinterface. In embodiments where the mount 9108 is made of a plastic, themount 9108 may be molded in a first “shot” of injection molding, and theseal 9208 may be overmolded onto the mount 9108 in a second “shot” ofinjection molding. Accordingly, the mount 9108 may be referred to orotherwise characterized as a “two-shot mount.”

In the illustrated embodiment, the seal 9208 may be overmolded onto themount 9108 at the pedestal 9204 and also on the bottom of the mount9108. More specifically, the seal 9208 may define or otherwise provide afirst seal element 9210 a overmolded onto the pedestal 9204, and asecond seal element 9210 b (FIG. 92B) interconnected to (with) the firstseal element 9210 a and overmolded onto the mount 9108 at the bottom ofthe mount 9108. In some embodiments, one or both of the seal elements9210 a,b may help form corresponding portions (sections) of the secondaperture 9202 b. While the seal 9208 is described herein as beingovermolded onto the mount 9108, it is also contemplated herein that oneor both of the seal elements 9210 a,b may comprise an elastomericcomponent part independent of the mount 9208, such as an O-ring or agasket.

The sensor control device 9102 may further include a collar 9212, whichmay be a generally annular structure that defines a central aperture9214. The central aperture 9214 may be sized to receive the first sealelement 9210 a and may align with both the first and second apertures9202 a,b when the sensor control device 9102 is properly assembled. Theshape of the central aperture 9214 may generally match the shape of thesecond aperture 9202 b and the first seal element 9210 a.

In some embodiments, the collar 9212 may define or otherwise provide anannular lip 9216 on its bottom surface. The annular lip 9216 may besized and otherwise configured to mate with or be received into thechannel 9206 defined on the inner surface of the mount 9108. In someembodiments, a groove 9218 may be defined on the annular lip 9216 andmay be configured to accommodate or otherwise receive a portion of thesensor 9112 extending laterally within the mount 9108. In someembodiments, the collar 9212 may further define or otherwise provide acollar channel 9220 (FIG. 92A) on its upper surface sized to receive andotherwise mate with an annular ridge 9222 (FIG. 92B) defined on theinner surface of the shell 9106 when the sensor control device 9102 isproperly assembled.

The sensor 9112 may include a tail 9224 that extends through the secondaperture 9202 b defined in the mount 9108 to be transcutaneouslyreceived beneath a user's skin. The tail 9224 may have an enzyme orother chemistry included thereon to help facilitate analyte monitoring.The sharp 9114 may include a sharp tip 9226 extendable through the firstaperture 9202 a defined by the shell 9106. As the sharp tip 9226penetrates the electronics housing 9104, the tail 9224 of the sensor9112 may be received within a hollow or recessed portion of the sharptip 9226. The sharp tip 9226 may be configured to penetrate the skinwhile carrying the tail 9224 to put the active chemistry of the tail9224 into contact with bodily fluids.

The sensor control device 9102 may provide a sealed subassembly thatincludes, among other component parts, portions of the shell 9106, thesensor 9112, the sharp 9114, the seal 9208, the collar 9212, and thesensor cap 9120. The sealed subassembly may help isolate the sensor 9112and the sharp 9114 within the inner chamber 9124 (FIG. 92A) of thesensor cap 9120. In assembling the sealed subassembly, the sharp tip9226 is advanced through the electronics housing 9104 until the sharphub 9116 engages the seal 9208 and, more particularly, the first sealelement 9210 a. The mating member 9118 provided at the bottom of thesharp hub 9116 may extend out the second aperture 9202 b in the bottomof the mount 9108, and the sensor cap 9120 may be coupled to the sharphub 9116 at the mating member 9118. Coupling the sensor cap 9120 to thesharp hub 9116 at the mating member 9118 may urge the first end 9122 aof the sensor cap 9120 into sealed engagement with the seal 9208 and,more particularly, into sealed engagement with the second seal element9210 b on the bottom of the mount 9108. In some embodiments, as thesensor cap 9120 is coupled to the sharp hub 9116, a portion of the firstend 9122 a of the sensor cap 9120 may bottom out (engage) against thebottom of the mount 9108, and the sealed engagement between the sensorhub 9116 and the first seal element 9210 a may be able to assume anytolerance variation between features.

FIG. 93 is a cross-sectional side view of the sensor control device9102, according to one or more embodiments. As indicated above, thesensor control device 9102 may include or otherwise incorporate a sealedsubassembly 9302, which may be useful in isolating the sensor 9112 andthe sharp 9114 within the inner chamber 9124 of the sensor cap 9120. Toassemble the sealed subassembly 9302, the sensor 9112 may be locatedwithin the mount 9108 such that the tail 9224 extends through the secondaperture 9202 b at the bottom of the mount 9108. In at least oneembodiment, a locating feature 9304 may be defined on the inner surfaceof the mount 9108, and the sensor 9112 may define a groove 9306 that ismatable with the locating feature 9304 to properly locate the sensor9112 within the mount 9108.

Once the sensor 9112 is properly located, the collar 9212 may beinstalled on the mount 9108. More specifically, the collar 9212 may bepositioned such that the first seal element 9210 a of the seal 9208 isreceived within the central aperture 9214 defined by the collar 9212 andthe first seal element 9210 a generates a radial seal against the collar9212 at the central aperture 9214. Moreover, the annular lip 9216defined on the collar 9212 may be received within the channel 9206defined on the mount 9108, and the groove 9218 defined through theannular lip 9216 may be aligned to receive the portion of the sensor9112 that traverses the channel 9206 laterally within the mount 9108. Insome embodiments, an adhesive may be injected into the channel 9206 tosecure the collar 9212 to the mount 9108. The adhesive may alsofacilitate a sealed interface between the two components and generate aseal around the sensor 9112 at the groove 9218, which may isolate thetail 9224 from the interior of the electronics housing 9104.

The shell 9106 may then be mated with or otherwise coupled to the mount9108. In some embodiments, as illustrated, the shell 9106 may mate withthe mount 9108 via a tongue-and-groove engagement 9308 at the outerperiphery of the electronics housing 9104. An adhesive may be injected(applied) into the groove portion of the engagement 9308 to secure theshell 9106 to the mount 9108, and also to create a sealed engagementinterface. Mating the shell 9106 to the mount 9108 may also cause theannular ridge 9222 defined on the inner surface of the shell 9106 to bereceived within the collar channel 9220 defined on the upper surface ofthe collar 9212. In some embodiments, an adhesive may be injected intothe collar channel 9220 to secure the shell 9106 to the collar 9212, andalso to facilitate a sealed interface between the two components at thatlocation. When the shell 9106 mates with the mount 9108, the first sealelement 9210 a may extend at least partially through (into) the firstaperture 9202 a defined in the shell 9106.

The sharp 9114 may then be coupled to the sensor control device 9102 byextending the sharp tip 9226 through the aligned first and secondapertures 9202 a,b defined in the shell 9106 and the mount 9108,respectively. The sharp 9114 may be advanced until the sharp hub 9116engages the seal 9208 and, more particularly, engages the first sealelement 9210 a. The mating member 9118 may extend (protrude) out thesecond aperture 9202 b at the bottom of the mount 9108 when the sharphub 9116 engages the first seal element 9210 a.

The sensor cap 9120 may then be removably coupled to the sensor controldevice 9102 by threadably mating the internal threads 9128 b of thesensor cap 9120 with the external threads 9128 a of the mating member9118. The inner chamber 9124 may be sized and otherwise configured toreceive the tail 9224 and the sharp tip 9226 extending from the bottomof the mount 9108. Moreover, the inner chamber 9124 may be sealed toisolate the tail 9224 and the sharp tip 9226 from substances that mightadversely interact with the chemistry of the tail 9224. In someembodiments, a desiccant (not shown) may be present within the innerchamber 9124 to maintain proper humidity levels.

Tightening (rotating) the mated engagement between the sensor cap 9120and the mating member 9118 may urge the first end 9122 a of the sensorcap 9120 into sealed engagement with the second seal element 9210 b inan axial direction (e.g., along the centerline of the apertures 9202a,b), and may further enhance the sealed interface between the sharp hub9116 and the first seal element 9210 a in the axial direction. Moreover,tightening the mated engagement between the sensor cap 9120 and themating member 9118 may compress the first seal element 9210 a, which mayresult in an enhanced radial sealed engagement between the first sealelement 9210 a and the collar 9212 at the central aperture 9214.Accordingly, in at least one embodiment, the first seal element 9210 amay help facilitate axial and radial sealed engagements.

As mentioned above, the first and second seal elements 9210 a,b may beovermolded onto the mount 9108 and may be physically linked or otherwiseinterconnected. Consequently, a single injection molding shot may flowthrough the second aperture 9202 b of the mount 9108 to create both endsof the seal 9208. This may prove advantageous in being able to generatemultiple sealed interfaces with only a single injection molded shot. Anadditional advantage of a two-shot molded design, as opposed to usingseparate elastomeric components (e.g., O-rings, gaskets, etc.), is thatthe interface between the first and second shots is a reliable bondrather than a mechanical seal. Hence, the effective number of mechanicalsealing barriers is effectively cut in half. Moreover, a two-shotcomponent with a single elastomeric shot also has implications tominimizing the number of two-shot components needed to achieve all thenecessary sterile barriers.

Once properly assembled, the sealed subassembly 9302 may be subjected toa radiation sterilization process to sterilize the sensor 9112 and thesharp 9114. The sealed subassembly 9302 may be subjected to theradiation sterilization prior to or after coupling the sensor cap 9120to the sharp hub 9116. When sterilized after coupling the sensor cap9120 to the sharp hub 9116, the sensor cap 9120 may be made of amaterial that permits the propagation of radiation therethrough. In someembodiments, the sensor cap 9120 may be transparent or translucent, butcan otherwise be opaque, without departing from the scope of thedisclosure.

FIG. 93A is an exploded isometric view of a portion of anotherembodiment of the sensor control device 9102 of FIGS. 91A-91B and92A-92B. Embodiments included above describe the mount 9108 and the seal9208 being manufactured via a two-shot injection molding process. Inother embodiments, however, as briefly mentioned above, one or both ofthe seal elements 9210 a,b of the seal 9208 may comprise an elastomericcomponent part independent of the mount 9208. In the illustratedembodiment, for example, the first seal element 9210 a may be overmoldedonto the collar 9212 and the second seal element 9210 b may beovermolded onto the sensor cap 9120. Alternatively, the first and secondseal elements 9210 a,b may comprise a separate component part, such as agasket or O-ring positioned on the collar 9212 and the sensor cap 9120,respectively. Tightening (rotating) the mated engagement between thesensor cap 9120 and the mating member 9118 may urge the second sealelement 9210 b into sealed engagement with the bottom of the mount 9108in an axial direction, and may enhance a sealed interface between thesharp hub 9116 and the first seal element 9210 a in the axial direction.

FIG. 94A is an isometric bottom view of the mount 9108, and FIG. 94B isan isometric top view of the sensor cap 9120, according to one or moreembodiments. As shown in FIG. 94A, the mount 9108 may provide orotherwise define one or more indentations or pockets 9402 at or near theopening to the second aperture 9202 b. As shown in FIG. 94B, the sensorcap 9120 may provide or otherwise define one or more projections 9404 ator near the first end 9122 a of the sensor cap 9120. The projections9404 may be received within the pockets 9402 when the sensor cap 9120 iscoupled to the sharp hub 9116 (FIGS. 92A-92B and 93). More specifically,as described above, as the sensor cap 9120 is coupled to the matingmember 9118 (FIGS. 92A-92B and 93) of the sensor hub 9116, the first end9122 a of the sensor cap 9120 is brought into sealed engagement with thesecond seal element 9210 b. In this process, the projections 9404 mayalso be received within the pockets 9402, which may help preventpremature unthreading of the sensor cap 9120 from the sharp hub 9116.

FIGS. 95A and 95B are side and cross-sectional side views, respectively,of an example sensor applicator 9502, according to one or moreembodiments. The sensor applicator 9502 may be similar in some respectsto the sensor applicator 102 of FIG. 1 and, therefore, may be designedto deliver (fire) a sensor control device, such as the sensor controldevice 9102. FIG. 95A depicts how the sensor applicator 9502 might beshipped to and received by a user, and FIG. 95B depicts the sensorcontrol device 9102 arranged within the interior of the sensorapplicator 9502.

As shown in FIG. 95A, the sensor applicator 9502 includes a housing 9504and an applicator cap 9506 removably coupled to the housing 9504. Insome embodiments, the applicator cap 9506 may be threaded to the housing9504 and include a tamper ring 9508. Upon rotating (e.g., unscrewing)the applicator cap 9506 relative to the housing 9504, the tamper ring9508 may shear and thereby free the applicator cap 9506 from the sensorapplicator 9502.

In FIG. 95B, the sensor control device 9102 is positioned within thesensor applicator 9502. Once the sensor control device 9102 is fullyassembled, it may then be loaded into the sensor applicator 9502 and theapplicator cap 9506 may be coupled to the sensor applicator 9502. Insome embodiments, the applicator cap 9506 and the housing 9504 may haveopposing, matable sets of threads that enable the applicator cap 9506 tobe screwed onto the housing 9504 in a clockwise (or counter-clockwise)direction and thereby secure the applicator cap 9506 to the sensorapplicator 9502.

Securing the applicator cap 9506 to the housing 9504 may also cause thesecond end 9122 b of the sensor cap 9120 to be received within a cappost 9510 located within the interior of the applicator cap 9506 andextending proximally from the bottom thereof. The cap post 9510 may beconfigured to receive at least a portion of the sensor cap 9120 as theapplicator cap 9506 is coupled to the housing 9504.

FIGS. 96A and 96B are perspective and top views, respectively, of thecap post 9510, according to one or more additional embodiments. In theillustrated depiction, a portion of the sensor cap 9120 is receivedwithin the cap post 9510 and, more specifically, the desiccant cap 9130of the sensor cap 9120 is arranged within cap post 9510.

The cap post 9510 may define a receiver feature 9602 configured toreceive the engagement feature 9126 of the sensor cap 9120 upon coupling(e.g., threading) the applicator cap 9506 (FIG. 95B) to the sensorapplicator 9502 (FIGS. 95A-95B). Upon removing the applicator cap 9506from the sensor applicator 9502, however, the receiver feature 9602 mayprevent the engagement feature 9126 from reversing direction and thusprevent the sensor cap 9120 from separating from the cap post 9510.Instead, removing the applicator cap 9506 from the sensor applicator9502 will simultaneously detach the sensor cap 9120 from the sensorcontrol device 9102 (FIGS. 91A-91B and 92A-92B), and thereby expose thedistal portions of the sensor 9112 (FIGS. 92A-92B) and the sharp 9114(FIGS. 92A-92B).

Many design variations of the receiver feature 9602 may be employed,without departing from the scope of the disclosure. In the illustratedembodiment, the receiver feature 9602 includes one or more compliantmembers 9604 (two shown) that are expandable or flexible to receive theengagement feature 9126. The engagement feature 9126 may comprise, forexample, an enlarged head and the compliant member(s) 9604 may comprisea collet-type device that includes a plurality of compliant fingersconfigured to flex radially outward to receive the enlarged head.

The compliant member(s) 9604 may further provide or otherwise definecorresponding ramped surfaces 9606 configured to interact with one ormore opposing camming surfaces 9608 provided on the outer wall of theengagement feature 9126. The configuration and alignment of the rampedsurface(s) 9606 and the opposing camming surface(s) 9608 is such thatthe applicator cap 9506 is able to rotate relative to the sensor cap9120 in a first direction A (e.g., clockwise), but the cap post 9510binds against the sensor cap 9120 when the applicator cap 9506 isrotated in a second direction B (e.g., counter clockwise). Moreparticularly, as the applicator cap 9506 (and thus the cap post 9510)rotates in the first direction A, the camming surfaces 9608 engage theramped surfaces 9606, which urge the compliant members 9604 to flex orotherwise deflect radially outward and results in a ratcheting effect.Rotating the applicator cap 9506 (and thus the cap post 9510) in thesecond direction B, however, will drive angled surfaces 9610 of thecamming surfaces 9608 into opposing angled surfaces 9612 of the rampedsurfaces 9606, which results in the sensor cap 9120 binding against thecompliant member(s) 9604.

FIG. 97 is a cross-sectional side view of the sensor control device 9102positioned within the applicator cap 9506, according to one or moreembodiments. As illustrated, the opening to the receiver feature 9602exhibits a first diameter D₃, while the engagement feature 9126 of thesensor cap 9120 exhibits a second diameter D₄ that is larger than thefirst diameter D₃ and greater than the outer diameter of the remainingportions of the sensor cap 9120. As the sensor cap 9120 is extended intothe cap post 9510, the compliant member(s) 9604 of the receiver feature9602 may flex (expand) radially outward to receive the engagementfeature 9126. In some embodiments, as illustrated, the engagementfeature 9126 may provide or otherwise define an angled outer surfacethat helps bias the compliant member(s) 9604 radially outward. Once theengagement feature 9126 bypasses the receiver feature 9602, thecompliant member(s) 9604 are able to flex back to (or towards) theirnatural state and thus lock the sensor cap 9120 within the cap post9510.

As the applicator cap 9506 is threaded to (screwed onto) the housing9504 (FIGS. 95A-95B) in the first direction A, the cap post 9510correspondingly rotates in the same direction and the sensor cap 9120 isprogressively introduced into the cap post 9510. As the cap post 9510rotates, the ramped surfaces 9606 of the compliant members 9604 ratchetagainst the opposing camming surfaces 9608 of the sensor cap 9120. Thiscontinues until the applicator cap 9506 is fully threaded onto (screwedonto) the housing 9504. In some embodiments, the ratcheting action mayoccur over two full revolutions of the applicator cap 9506 before theapplicator cap 9506 reaches its final position.

To remove the applicator cap 9506, the applicator cap 9506 is rotated inthe second direction B, which correspondingly rotates the cap post 9510in the same direction and causes the camming surfaces 9608 (i.e., theangled surfaces 9610 of FIGS. 96A-96B) to bind against the rampedsurfaces 9606 (i.e., the angled surfaces 9612 of FIGS. 96A-96B).Consequently, continued rotation of the applicator cap 9506 in thesecond direction B causes the sensor cap 9120 to correspondingly rotatein the same direction and thereby unthread from the mating member 9118to allow the sensor cap 9120 to detach from the sensor control device9102. Detaching the sensor cap 9120 from the sensor control device 9102exposes the distal portions of the sensor 9112 and the sharp 9114, andthus places the sensor control device 9102 in position for firing (use).

FIG. 98 is a cross-sectional view of a sensor control device 9800showing example interaction between the sensor and the sharp. Afterassembly of the sharp, the sensor should sit in a channel defined by thesharp. The sensor control device in FIG. 9 does not show the sensordeflected inwards and otherwise aligned fully with the sharp, but suchmay be the case upon full assembly as slight bias forces may be assumedby the sensor at the locations indicated by the two arrows A. Biasingthe sensor against the sharp may be advantageous so that any relativemotion between the sensor and the sharp during subcutaneous insertiondoes not expose the sensor tip (i.e., the tail) outside the sharpchannel, which could potentially cause an insertion failure.

Embodiments disclosed herein include:

CC. A sensor control device that includes an electronics housingincluding a shell that defines a first aperture and a mount that definesa second aperture alignable with the first aperture when the shell iscoupled to the mount, a seal overmolded onto the mount at the secondaperture and comprising a first seal element overmolded onto a pedestalprotruding from an inner surface of the mount, and a second seal elementinterconnected with the first seal element and overmolded onto a bottomof the mount, a sensor arranged within the electronics housing andhaving a tail extending through the second aperture and past the bottomof the mount, and a sharp that extends through the first and secondapertures and past the bottom of the electronics housing.

DD. An assembly that includes a sensor applicator, a sensor controldevice positioned within the sensor applicator and including anelectronics housing including a shell that defines a first aperture anda mount that defines a second aperture alignable with the first aperturewhen the shell is mated to the mount, a seal overmolded onto the mountat the second aperture and comprising a first seal element overmoldedonto a pedestal protruding from an inner surface of the mount, and asecond seal element interconnected with the first seal element andovermolded onto a bottom of the mount, a sensor arranged within theelectronics housing and having a tail extending through the secondaperture and past the bottom of the mount, and a sharp that extendsthrough the first and second apertures and past the bottom of theelectronics housing. The assembly further including a sensor capremovably coupled to the sensor control device at the bottom of themount and defining a sealed inner chamber that receives the tail and thesharp, and an applicator cap coupled to the sensor applicator.

Each of embodiments CC and DD may have one or more of the followingadditional elements in any combination: Element 1: wherein the mountcomprises a first injection molded part molded in a first shot, and theseal comprises a second injection molded part overmolded onto the firstinjection molded part in a second shot. Element 2: further comprising asharp hub that carries the sharp and sealingly engages the first sealelement, and a sensor cap removably coupled to the sharp hub at thebottom of the mount and sealingly engaging the second seal element,wherein the sensor cap defines an inner chamber that receives the tailand the sharp. Element 3: wherein the sharp hub provides a mating memberthat extends past the bottom of the mount and the sensor cap isremovably coupled to the mating member. Element 4: further comprisingone or more pockets defined on the bottom of the mount at the secondaperture, and one or more projections defined on an end of the sensorcap and receivable within the one or more pockets when the sensor cap iscoupled to the sharp hub. Element 5: further comprising a collarpositioned within the electronics housing and defining a centralaperture that receives and sealingly engages the first seal element in aradial direction. Element 6: further comprising a channel defined on theinner surface of the mount and circumscribing the pedestal, an annularlip defined on an underside of the collar and matable with the channel,and an adhesive provided in the channel to secure and seal the collar tothe mount at the channel. Element 7: further comprising a groove definedthrough the annular lip to accommodate a portion of the sensor extendinglaterally within the mount, wherein the adhesive seals about the sensorat the groove. Element 8: further comprising a collar channel defined onan upper surface of the collar, an annular ridge defined on an innersurface of the shell and matable with the collar channel, and anadhesive provided in the collar channel to secure and seal the shell tothe collar. Element 9: wherein one or both of the first and second sealelements define at least a portion of the second aperture. Element 10:wherein the first seal element extends at least partially through thefirst aperture when the shell is coupled to the mount.

Element 11: wherein the sensor control device further includes a sharphub that carries the sharp and sealingly engages the first seal element,and wherein the sensor cap is removably coupled to the sharp hub at thebottom of the mount and sealingly engages the second seal element.Element 12: wherein the sensor control device further includes one ormore pockets defined on the bottom of the mount at the second aperture,and one or more projections defined on an end of the sensor cap andreceivable within the one or more pockets when the sensor cap is coupledto the sharp hub. Element 13: wherein the sensor control device furtherincludes a collar positioned within the electronics housing and defininga central aperture that receives and sealingly engages the first sealelement in a radial direction. Element 14: wherein the sensor controldevice further includes a channel defined on the inner surface of themount and circumscribing the pedestal, an annular lip defined on anunderside of the collar and matable with the channel, and an adhesiveprovided in the channel to secure and seal the collar to the mount atthe channel. Element 15: wherein the sensor control device furtherincludes a groove defined through the annular lip to accommodate aportion of the sensor extending laterally within the mount, and whereinthe adhesive seals about the sensor at the groove. Element 16: whereinthe sensor control device further includes a collar channel defined onan upper surface of the collar, an annular ridge defined on an innersurface of the shell and matable with the collar channel, and anadhesive provided in the collar channel to secure and seal the shell tothe collar. Element 17: wherein one or both of the first and second sealelements define at least a portion of the second aperture. Element 18:wherein the first seal element extends at least partially through thefirst aperture.

By way of non-limiting example, exemplary combinations applicable to CCand DD include: Element 2 with Element 3; Element 2 with Element 4;Element 5 with Element 6; Element 6 with Element 7; Element 5 withElement 8; Element 11 with Element 12; Element 13 with Element 14;Element 14 with Element 15; and Element 13 with Element 16.

Axial-Radial Thermal Cycle Resistant Cap Seal

FIG. 99 is a cross-sectional side view of an example analyte monitoringsystem enclosure 9900 used to house at least a portion of the sensorcontrol device 104 of FIG. 1, according to one or more embodiments. Asillustrated, the analyte monitoring system enclosure 9900 includes thesensor applicator 102 and the applicator cap 210 matable with the sensorapplicator 102. The applicator cap 210 provides a barrier that protectsthe internal contents of the sensor applicator 102. In some embodiments,the applicator cap 210 may be secured to the housing 208 by a threadedengagement and, upon rotating (e.g., unscrewing) the applicator cap 210relative to the housing 208, the applicator cap 210 can be freed fromthe sensor applicator 102. In other embodiments, however, the applicatorcap 210 may be secured to the housing 208 via an interference or shrinkfit engagement.

As described herein below, the coupled engagement between the sensorapplicator 102 and the applicator cap 210 may prove vital in properlysterilizing the components positioned within the sensor applicator 102and maintaining a sterile environment as sealed with the applicator cap210. The embodiments described herein below may be applicable to analytemonitoring systems that incorporate a two-piece or a one-piecearchitecture. More particularly, in embodiments employing a two-piecearchitecture, the electronics housing (not shown) that retains theelectrical components for the sensor control device 104 (FIG. 1) may bepositioned within the sensor applicator 102 and the applicator cap 210maintains the sterile environment. In contrast, in embodiments employinga one-piece architecture, the sensor applicator 102 may contain thefully assembled sensor control device 104 (not shown), and theapplicator cap 210 maintains the sterile environment for the fullyassembled sensor control device.

The components arranged within the sensor applicator 102 and sealed withthe applicator cap 210 may be subjected to gaseous chemicalsterilization 9902 configured to sterilize exposed portions of suchcomponents. To accomplish this, a chemical may be injected into asterilization chamber 9904 cooperatively defined by the housing 208 andthe interconnected cap 210. In some applications, the chemical may beinjected into the sterilization chamber 9904 via one or more vents 9906(two shown) defined in the applicator cap 210 at its proximal end 9908.Example chemicals that may be used for the gaseous chemicalsterilization 9902 include, but are not limited to, ethylene oxide,vaporized hydrogen peroxide, and nitrogen oxide (e.g., nitrous oxide,nitrogen dioxide, etc.).

Once a desired sterility assurance level has been achieved within thesterilization chamber 9904, the gaseous solution may be evacuated viathe vents 9906 and the sterilization chamber 9904 is aerated. Aerationmay be achieved by a series of vacuums and subsequently circulatingnitrogen gas or filtered air through the sterilization chamber 9904.Once the sterilization chamber 9904 is properly aerated, the vents 9906may be occluded with a seal 9910 (shown in dashed lines).

In some embodiments, the seal 9910 may comprise two or more layers ofdifferent materials. The first layer may be made of a synthetic material(e.g., a flash-spun high-density polyethylene fiber), such as Tyvek®available from DuPont®. Tyvek® is highly durable and puncture resistantand allows the permeation of vapors. The Tyvek® layer can be appliedbefore the gaseous chemical sterilization process, and following thegaseous chemical sterilization process, a foil or other vapor andmoisture resistant material layer may be sealed (e.g., heat sealed) overthe Tyvek® layer to prevent the ingress of contaminants and moistureinto the sterilization chamber 9904. In other embodiments, the seal 9910may comprise only a single protective layer applied to the applicatorcap 210. In such embodiments, the single layer is gas permeable for thesterilization process, but is also capable of protection againstmoisture and other harmful elements once the sterilization process iscomplete.

With the seal 9910 in place, the applicator cap 210 provides a barrieragainst outside contamination, and thereby maintains a sterileenvironment for the components arranged within the sensor applicator 102until the user removes (unthreads) the applicator cap 210 from thehousing 208.

FIG. 100A is an enlarged cross-sectional side view of the interfacebetween the sensor applicator 102 and the applicator cap 210, asindicated by the dashed box of FIG. 99. As illustrated the housing 208provides a first axial extension 10002 a and the applicator cap 210provides a second axial extension 10002 b matable with the first axialextension 10002 a. In the illustrated embodiment, the diameter of thesecond axial extension 10002 b of the applicator cap 210 is sized toreceive the diameter of the first axial extension 10002 a of the housing208. In other embodiments, however, the reverse may be employed, wherethe diameter of the first axial extension 10002 a may be sized toreceive the diameter of the second axial extension 10002 b, withoutdeparting from the scope of the disclosure.

In either scenario, a radial seal 10004 may be defined or otherwiseprovided at the interface between the first and second axial extensions10002 a,b and the radial seal 10004 may help prevent migration of fluidsor contaminants across the interface in either axial direction. In theillustrated embodiment, the radial seal 10004 comprises a radialprotrusion formed on the inner radial surface of the second axialextension 10002 b. In other embodiments, however, the radial seal 10004may alternatively be formed on the outer radial surface of the firstaxial extension 10002 a, without departing from the scope of thedisclosure. In embodiments where the second axial extension 10002 b isreceived within the first axial extension 10002 a, the radial seal 10004may be formed on the inner radial surface of the first axial extension10002 a or alternatively on the outer radial surface of the second axialextension 10002 b.

Gaseous chemical sterilization 9902 (FIG. 99) is commonly undertaken atelevated temperatures reaching 60° C. (140° F.) or more. At suchelevated temperatures, the housing 208 and the applicator cap 210 may besubjected to thermal expansion that may affect the integrity of theradial seal 10004. The housing 208 and the applicator cap 210 may bemade of dissimilar materials that have dissimilar coefficients ofthermal expansion. In some embodiments, for example, the housing 208 maybe made of polycarbonate and the applicator cap 210 may be made ofpolypropylene. Polypropylene exhibits a coefficient of thermal expansionof about 100-180 10⁻⁶K⁻¹ and polycarbonate exhibits a coefficient ofthermal expansion of about 66-70 10⁻⁶K⁻¹. Since polypropylene has athermal coefficient that is higher than polycarbonate, the applicatorcap 210 will tend to expand at a greater rate than the polycarbonatehousing 208 during gaseous chemical sterilization 9902. Moreover, theincreased expansion of the applicator cap 210 can affect the sealintegrity (capability) of the radial seal 10004.

FIG. 100B is an enlarged cross-sectional side view of the interfacebetween the sensor applicator 102 and the applicator cap 210, asindicated by the dashed box of FIG. 99 during and/or after gaseouschemical sterilization. Since the applicator cap 210 exhibits a thermalcoefficient greater than the thermal coefficient of the housing 208, theapplicator cap 210 expands at a greater rate than the housing 208 uponbeing subjected to the elevated temperatures required for gaseouschemical sterilization 9902 (FIG. 99). Consequently, a gap 10006 may becreated between the opposing radial surfaces of the first and secondaxial extensions 10002 a,b as the radial seal 10004 separates fromopposed radial engagement. As shown by the arrows, the gap 10006 mayprovide a flow path for the outflow of toxic gases used for gaseouschemical sterilization 9902.

Following gaseous chemical sterilization 9902, and as the temperature islowered to ambient, the applicator cap 210 may radially contract and thegap 10006 may close, thereby sealing the interface at the radial seal10004 once again. Such embodiments may prove advantageous in simplifyingthe design of the applicator cap 210. More specifically, and accordingto one or more embodiments of the present disclosure, the gaseouschemical sterilization 9902 process may be carried out entirely throughthe gap 10006 formed between the opposing radial surfaces of the firstand second axial extensions 10002 a,b. In such embodiments, thetemperature of the housing 208 and the applicator cap 210 may beelevated until the gap 10006 is created. Once the gap 10006 is created,the gaseous chemicals (e.g., ethylene oxide) used during the gaseouschemical sterilization 9902 may be injected into the sterilizationchamber 9904 through the gap 10006 and otherwise by bypassing the radialseal 10004. The sterilization chamber 9904 may be subsequently aeratedby drawing out the gaseous chemicals through the gap 10006 andcirculating another fluid, such as nitrogen, into and out of thesterilization chamber 9904 via the gap 10006.

In such embodiments, the vents 9906 (FIG. 99) defined in the applicatorcap 210 and the seal 9910 (FIG. 99) attached to the bottom of theapplicator cap 210 may be omitted and otherwise unnecessary.Accordingly, in such embodiments, the bottom of the applicator cap 210may be solid. Moreover, in such embodiments, a desiccant may bepositioned within the applicator cap 210 or the sterilization chamber9904 to aid maintenance of a low humidity environment for biologicalcomponents sensitive to moisture.

In other embodiments, however, the applicator cap 210 may undergo stressrelaxation at the enlarged diameter during gaseous chemicalsterilization 9902. This may occur in embodiments where the material ofthe applicator cap 210 exhibits a thermal coefficient greater than thematerial of the housing 208 and the gaseous chemical sterilization 9902spans a long period of time (e.g., one hour, five hours, ten hours,fifteen hours, or more). As the temperature is lowered to ambient, theapplicator cap 210 may remain substantially at the enlarged diameter andthe gap 10006 may correspondingly remain, which jeopardizes theintegrity of the radial seal 10004.

Stress relaxation of the applicator cap 210 may also occur inembodiments where the housing 208 is made of a material that has ahigher thermal coefficient than the applicator cap 210. In suchembodiments, the housing 208 will expand at a greater rate than theapplicator cap 210 and thereby radially expand against the applicatorcap 210. The gap 10006 will not be generated as the housing 208continuously biases against the applicator cap 210 during thermalexpansion. The material of the applicator cap 210, however, will undergostress relaxation at an enlarged diameter, and upon cooling the systemto ambient, the gap 10006 may be generated as the housing 208 radiallycontracts but the applicator cap 210 remains near the enlarged diameter.The resulting gap 10006 compromises the sealed interface at the radialseal 10004, and thereby prevents the applicator cap 210 from providing abarrier.

FIG. 101 is an enlarged cross-sectional side view of another exampleanalyte monitoring system enclosure 10100 used to house at least aportion of the sensor control device 104 of FIG. 1, according to one ormore embodiments. Similar to the analyte monitoring system enclosure9900 of FIGS. 99 and 1007A-100B, the analyte monitoring system enclosure10100 includes the sensor applicator 102 and the applicator cap 210matable with the sensor applicator 102. In the illustrated embodiment,the applicator cap 210 is secured to the housing 208 by complimentarymating threads 10102, and may include a tamper ring 10104. Upon rotating(e.g., unscrewing) the applicator cap 210 relative to the housing 208,the tamper ring 10104 may shear and thereby free the applicator cap 210from the sensor applicator 102.

As best seen in the enlarged view, the interface between the housing 208and the applicator cap 210 may provide or otherwise define a radial seal10106 and an axial-radial seal 10108. More specifically, the housing 208may provide a first axial extension 10110 a and the applicator cap 210may provide a second axial extension 10110 b extending in the oppositedirection. In the illustrated embodiment, the diameter of the firstaxial extension 10110 a may be sized to receive the smaller diametersecond axial extension 10110 b of the applicator cap 210. In otherembodiments, however, the diameter of the second axial extension 10110 bmay be sized to receive a smaller diameter first axial extension 10110 aof the housing 208, without departing from the scope of the disclosure.

In either scenario, the radial seal 10106 may be defined or otherwiseprovided at an interface between the first and second axial extensions10110 a,b and configured to help prevent the migration of fluids orcontaminants across the interface in either axial direction. In theillustrated embodiment, the radial seal 10106 comprises a radialprotrusion 10107 formed on the outer radial surface of the second axialextension 10110 b, but the radial protrusion 10107 may alternatively beformed on the inner radial surface of the first axial extension 10110 a,without departing from the scope of the disclosure. In embodiments wherethe first axial extension 10110 a is received within the second axialextension 10110 b, the radial seal 10106 may be formed on the outerradial surface of the first axial extension 10110 a or alternatively onthe inner radial surface of the second axial extension 10110 b.

As its name suggests, the axial-radial seal 10108 may be configured toprovide a sealed interface between the housing 208 and the applicatorcap 210 in both axial and radial directions, and thereby prevent themigration of fluids or contaminants across the interface in both axialand radial directions. To accomplish this, the axial-radial seal 10108may comprise a beveled or chamfered surface 10112 configured to matewith a fillet 10114, where the fillet 10114 comprises angularly offsetsurfaces angled to substantially mate with the angled profile of thechamfered surface 10112 in both axial and radial directions. In theillustrated embodiment, the chamfered surface 10112 is defined on theend of the second axial extension 10110 b and the fillet 10114 isdefined by the first axial extension 10110 a. In other embodiments,however, the chamfered surface 10112 may alternatively be defined on theend of the first axial extension 10110 a and the fillet 10114 may bedefined by the second axial extension 10110 b, without departing fromthe scope of the disclosure.

The radial seal 10106 and the axial-radial seal 10108 may be configuredto cooperatively help maintain fluid tight interfaces between thehousing 208 and the applicator cap 210. During gaseous chemicalsterilization 9902 (FIG. 99), however, and since the housing 208 and theapplicator cap 210 may be made of dissimilar materials having dissimilarcoefficients of thermal expansion, the elevated temperatures may resultin loss of a fluid tight seal at the radial seal 10106. Nonetheless, theaxial-radial seal 10108 may be designed and otherwise configured tomaintain a fluid tight interface between the housing 208 and theapplicator cap 210 while withstanding the elevated temperatures ofgaseous chemical sterilization 9902. Regardless of the materials ofeither of the housing 208 or the applicator cap 210, and regardless ofthe respective coefficients of thermal expansion, the axial-radial seal10108 may prove advantageous in maintaining a fluid tight interface. Insome embodiments, the applicator cap 210 may provide a sterile barrier.

FIGS. 102A-102C depict finite element analysis (FEA) resultscorresponding to the interface between the housing 208 and theapplicator cap 210 during example gaseous chemical sterilization,according to one or more embodiments. FIG. 102A depicts FEA analysisresults as the applicator cap 210 is secured to the housing 208, such asby screwing the applicator cap 210 onto the housing 208 via the threads10102 (FIG. 101). As illustrated, a radial preload may be generated atthe radial seal 10106 as the radial protrusion 10107 provided on thesecond axial extension 10110 b is urged into radial contact with theinner radial surface of the first axial extension 10110 a. Moreover, acombination axial and radial preload may be generated at theaxial-radial seal 10108 as the chamfered surface 10112 is urged intoboth axial and radial engagement with the fillet 10114.

FIG. 102B depicts FEA analysis results during an increase in temperatureresulting from gaseous chemical sterilization. The temperature increaseresults in differential expansion between the materials of the housing208 and cap 210. Depending on the materials chosen, the applicator cap210 may expand radially more or less than the housing 208. During thistemperature increase and the radial expansion of the housing 208 and theapplicator cap 210, the axial-radial seal 10108 remains intact as thechamfered surface 10112 is wedged into both axial and radial engagementwith the fillet 10114. Hence, the expansion of the fillet 10114 maydictate the final position of the axial-radial seal 10108 at elevatedtemperature. Depending upon whether the housing 208 material has ahigher coefficient of thermal expansion than the applicator cap 210material, or vice-versa, this result may or may not apply to the radialseal 10106.

The elevated temperatures during gaseous chemical sterilization aretypically maintained for long periods of time. During this time, stressrelaxation may occur in all the stressed zones of the applicator cap 210and insignificant residual stress is expected at the end of thetemperature cycle. This implies that most of the preload (and hencesealing) is lost at elevated temperature.

FIG. 102C depicts FEA analysis results after decreasing the temperaturefollowing gaseous chemical sterilization. In embodiments where theapplicator cap 210 is made of a material having a higher coefficient ofthermal expansion than the housing 208, the radial seal 10106 is likelylost upon decreasing the temperature to ambient due to stress relaxationat the elevated temperature. As a result, separation of the first andsecond axial extensions 10110 a,b occurs and a gap 2816 is formedbetween the two surfaces after cooling. In contrast, in embodimentswhere the housing 208 is made of a material having a higher coefficientof thermal expansion than the applicator cap 210, the radial seal 10106may be re-activated following cooling. In either scenario, however, theaxial-radial seal 10108 may remain intact throughout the temperaturecycle as the chamfered surface 10112 is continuously wedged into bothaxial and radial engagement with the fillet 10114. Accordingly, theaxial-radial seal 10108 may prove advantageous in maintaining sealedengagement between the housing 208 and the applicator cap 210 regardlessof the materials used.

Embodiments disclosed herein include:

EE. An analyte monitoring system enclosure including a sensor applicatorincluding a housing that provides a first axial extension, a cap matablewith the housing and providing a second axial extension, and anaxial-radial seal that seals an interface between the housing and thecap in both axial and radial directions, wherein the axial-radial sealincludes a fillet defined by one of the first and second axialextensions, and a chamfered surface matable with the fillet and definedon an end of the other of the first and second axial extensions.

FF. A method of sterilizing contents within an analyte monitoring systemenclosure including injecting a chemical gas into the analyte monitoringsystem enclosure, the analyte monitoring system enclosure comprising asensor applicator including a housing that provides a first axialextension, and a cap matable with the housing and providing a secondaxial extension. The method further including sealing an interfacebetween the housing and the cap in both axial and radial directions withan axial-radial seal, wherein the axial-radial seal includes a filletdefined by one of the first and second axial extensions, and a chamferedsurface matable with the fillet and defined on an end of the other ofthe first and second axial extensions, increasing and decreasing atemperature of the analyte monitoring system enclosure, and maintainingthe axial-radial seal as the temperature is increased and decreased.

GG. A method of sterilizing contents within an analyte monitoring systemenclosure including providing the analyte monitoring system enclosure,the analyte monitoring system enclosure comprising a sensor applicatorincluding a housing that provides a first axial extension, and a capmatable with the housing and providing a second axial extension. Themethod further including increasing a temperature of the analytemonitoring system enclosure until a gap forms between the first andsecond axial extensions, injecting a chemical gas into the analytemonitoring system enclosure through the gap, evacuating the chemical gasfrom the analyte monitoring system enclosure through the gap, anddecreasing the temperature of the analyte monitoring system and sealingan interface between the first and second axial extensions with a radialseal.

Each of embodiments EE, FF, and GG may have one or more of the followingadditional elements in any combination: Element 1: wherein the housingand the cap are made of dissimilar materials having dissimilarcoefficients of thermal expansion. Element 2: wherein the filletcomprises angularly offset surfaces angled to mate with an angledprofile of the chamfered surface in both the axial and radialdirections. Element 3: further comprising a radial seal provided betweenthe first and second axial extensions. Element 4: wherein the radialseal comprises a radial protrusion formed on an inner or outer surfaceof one of the first and second axial extensions. Element 5: wherein thefirst axial extension is received within the second axial extension andthe radial protrusion is formed on the outer surface of the first axialextension or the inner surface of the second axial extension. Element 6:wherein the second axial extension is received within the first axialextension and the radial protrusion is formed on the inner surface ofthe first axial extension or the outer surface of the second axialextension. Element 7: wherein the cap is secured to the housing via athreaded engagement.

Element 8: wherein maintaining the axial-radial seal comprises wedgingthe chamfered surface into one or both of axial and radial engagementwith the fillet as the temperature is increased and decreased. Element9: wherein the housing and the cap are made of dissimilar materialshaving dissimilar coefficients of thermal expansion. Element 10: furthercomprising radially sealing an interface between the housing and the capwith a radial seal. Element 11: wherein the radial seal comprises aradial protrusion formed on an inner radial surface or an outer radialsurface of one of the first and second axial extensions, and whereinradially sealing the interface comprises urging the radial protrusioninto engagement with an opposing surface of the other of the first andsecond axial extensions. Element 12: wherein the cap is secured to thehousing via a threaded engagement.

Element 13: wherein the housing and the cap are made of dissimilarmaterials having dissimilar coefficients of thermal expansion. Element14: wherein the radial seal comprises a radial protrusion formed on aninner radial surface or an outer radial surface of one of the first andsecond axial extensions, and wherein radially sealing the interfacecomprises urging the radial protrusion into engagement with an opposingsurface of the other of the first and second axial extensions. Element15: wherein the bottom of the cap is solid without vents formed therein.Element 16: further maintaining a low humidity environment within thecap with a desiccant.

By way of non-limiting example, exemplary combinations applicable to EE,FF, and GG include: Element 3 with Element 4; Element 4 with Element 5;Element 4 with Element 6; and Element 10 with Element 11.

Conversion Process for Sensor Control Devices

Referring again briefly to FIG. 1, the sensor control device 104 isoften included with the sensor applicator 104 in what is known as a“two-piece” architecture that requires final assembly by a user beforethe sensor 110 can be properly delivered to the target monitoringlocation. More specifically, the sensor 110 and the associatedelectrical components included in the sensor control device 104 areprovided to the user in multiple (two) packages, and the user must openthe packaging and follow instructions to manually assemble thecomponents before delivering the sensor 110 to the target monitoringlocation with the sensor applicator 102. More recently, advanced designsof sensor control devices and sensor applicators have resulted in aone-piece architecture that allows the system to be shipped to the userin a single, sealed package that does not require any final userassembly steps. Rather, the user need only open one package andsubsequently deliver the sensor control device to the target monitoringlocation. Notwithstanding these advancements, however, sensor controldevices are still frequently made of hard plastic materials that containseveral component parts.

According to the present disclosure, sensor control devices (e.g., thesensor control device 104) may alternatively be manufactured through aconverting process that incorporate large rolls of process material thatare progressively modified to form or otherwise assemble flexible sensorcontrol devices in step-wise fashion. The converting processes describedherein may use pressure sensitive adhesives (PSAs) or tapes,thermoformed films, die-cut or layered components, and other materialsthat readily lend themselves to roll-to-roll or other high volumemanufacturing processes. These high-volume manufacturing processes havethe potential to greatly decrease the cost of manufacturing sensorcontrol devices and increase the rate of assembly.

FIG. 103 is an isometric view of an example sensor control device 10302,according to one or more embodiments of the present disclosure. Thesensor control device 10302 may be the same as or similar to the sensorcontrol device 104 of FIG. 1 and, therefore, may be used in conjunctionwith the sensor applicator 102 (FIG. 1), which delivers the sensorcontrol device 10302 to a target monitoring location on a user's skin.

As illustrated, the sensor control device 10302 includes an electronicshousing 10304 that is generally planar in shape and can exhibit avariety of cross-sectional shapes. In the illustrated embodiment, theelectronics housing 10304 is rectangular with rounded corners, but couldexhibit other cross-sectional shapes, such as circular, oval, ovoid(e.g., pill- or egg-shaped), a squircle, another polygonal shape (e.g.,square, pentagonal, etc.), or any combination thereof, without departingfrom the scope of the disclosure. The electronics housing 10304 may beconfigured to house or otherwise contain various electronic componentsused to operate the sensor control device 10302.

The electronics housing 10304 may include an upper cover 10306 and alower cover 10308 that is matable with the upper cover 10306. In someembodiments, the upper and lower covers 10306, 10308 may comprise afilm, a foil, a foam, a laminated material (e.g., a laminated metal orfoil), a coextruded material, a cast film, a comolded material, or anycombination thereof. Accordingly, the upper and lower covers 10306,10308 may be made of a variety of semi-rigid or flexible materialsincluding, but not limited to, a plastic or thermoplastic, a metal, acomposite material (e.g., fiberglass, etc.), or any combination thereof.Moreover, the upper and lower covers 10306, 10308 may be formed via avariety of manufacturing processes including, but not limited to,thermoforming, vacuum forming, injection molding, die-cutting, stamping,compression molding, transfer molding, or any combination thereof.

The upper cover 10306 may be secured to the lower cover 10308 via avariety of mating techniques, such as sonic welding, ultrasonic welding,laser welding, heat sealing, an adhesive substrate (e.g., a pressuresensitive adhesive or tape), or any combination thereof. In some cases,the upper cover 10306 may be secured to the lower cover 10308 such thata sealed interface is generated therebetween. The sealed interface mayprovide structural integrity, but may also isolate the interior of theelectronics housing 10304 from outside contamination. In the illustratedembodiment, securing the upper cover 10306 to the lower cover 10308 mayresult in the formation of a flange 10322 extending about the peripheryof the electronics housing 10304. In other embodiments, however, theupper and lower covers 10306, 10308 may be secured without forming theflange 10322.

In the illustrated embodiment, the sensor control device 10302 mayoptionally include a plug assembly 10310 that may be coupled to theelectronics housing 10304. The plug assembly 10310 may include a sensormodule 10312 (partially visible) interconnectable with a sharp module10314 (partially visible). The sensor module 10312 may be configured tocarry and otherwise include a sensor 10316 (partially visible), and thesharp module 10314 may be configured to carry and otherwise include anintroducer or sharp 10318 (partially visible) used to help deliver thesensor 10316 transcutaneously under a user's skin during application ofthe sensor control device 10302. In the illustrated embodiment, thesharp module 10314 includes a sharp hub 10320 that carries the sharp10318.

As illustrated, corresponding portions of the sensor 10316 and the sharp10318 extend distally from the electronics housing 10304 and, moreparticularly, from the bottom of the lower cover 10308. In at least oneembodiment, the exposed portion of the sensor 10316 (alternatelyreferred to as the “tail”) may be received within a hollow or recessedportion of the sharp 10318. The remaining portions of the sensor 10316are positioned within the interior of the electronics housing 10304.

FIGS. 104A and 104B are exploded, isometric views of the sensor controldevice 10302 of FIG. 103, according to one or more embodiments. Morespecifically, FIG. 104A is an exploded, isometric view of a sensorelectronics module 10402 included in the sensor control device 10302,and FIG. 104B is an exploded, isometric view of the sensor controldevice 10302 with the sensor electronics module 10402.

Referring first to FIG. 104A, the sensor electronics module 10402 mayinclude a cap 10404, a sensor holder 10406, the sensor 10316, and aprinted circuit board (PCB) 10408. The cap 10404 and the sensor holder10406 may be made of injection molded plastic, for example, and may beconfigured to secure the sensor 10316 within the sensor electronicsmodule 10402. To accomplish this, the cap 10404 and the sensor holder10406 may be engageable and matable. In the illustrated embodiment, forexample, the cap 10404 includes or defines one or more castellations orprojections 10410 sized to be received within or mate with one or morecorresponding grooves or pockets 10412 defined on the sensor holder10406. Mating the projections 10410 with the pockets 10412 may helpsecure the sensor 10316 within the sensor electronics module 10402 andmay also clamp down on the PCB 10408 and the other component parts ofthe sensor electronics module 10402, thus resulting in a solidstructural component. In other embodiments, however, the projections10410 may alternatively be provided on the sensor holder 10406, and thecap 10404 may instead define the pockets 10412, without departing fromthe scope of the disclosure.

As illustrated, the sensor 10316 includes a tail 10314, a flag 10416,and a neck 10418 that interconnects the tail 10314 and the flag 10416.The tail 10314 may be configured to extend at least partially through achannel 10420 defined in the sensor holder 10406 and extend distallyfrom the sensor electronics module 10402. The tail 10314 includes anenzyme or other chemistry or biologic and, in some embodiments, amembrane may cover the chemistry. In use, the tail 10314 istranscutaneously received beneath a user's skin, and the chemistryincluded thereon helps facilitate analyte monitoring in the presence ofbodily fluids. The flag 10416 may comprise a generally planar surfacehaving one or more sensor contacts 10422 (three shown) arranged thereon.The sensor contacts 10422 may be configured to align with acorresponding number of circuitry contacts (not shown) included on thePCB 10408 that provide conductive communication between the sensor 10316and the electronic components provided on the PCB 10408.

In some embodiments, the PCB 10408 may be flexible, and may be sized tobe positioned within the electronics housing 10304 (FIG. 103). Aplurality of electronic modules (not shown) may be mounted to the PCB10408 including, but not limited to, a data processing unit, resistors,transistors, capacitors, inductors, diodes, and switches. The dataprocessing unit may comprise, for example, an application specificintegrated circuit (ASIC) configured to implement one or more functionsor routines associated with operation of the sensor control device 10302(FIGS. 103 and 104B). More specifically, the data processing unit may beconfigured to perform data processing functions, where such functionsmay include but are not limited to, filtering and encoding of datasignals, each of which corresponds to a sampled analyte level of theuser. The data processing unit may also include or otherwise communicatewith an antenna for communicating with the reader device 106 (FIG. 1).One or more batteries (not shown) may also be mounted to the PCB 10408and used to power the sensor control device 10302.

The sensor electronics module 10402 may further include one or moreadhesive substrates, shown as a first adhesive substrate 10424 a, asecond adhesive substrate 10424 b, and a third adhesive substrate 10424c. In some embodiments, each adhesive substrate 10424 a-c may comprise apressure-adhesive tape that forms a bond when pressure is applied. Thefirst adhesive substrate 10424 a may interpose the cap 10404 and the PCB10408 and may operate to secure the cap 10404 to the PCB 10408. Thesecond adhesive substrate 10424 b may interpose the sensor holder 10406and the sensor 10316 (i.e., the flag 10416) and may operate to securethe sensor 10316 to the sensor holder 10406.

The third adhesive substrate 10424 c may interpose the sensor 10316(i.e., the flag 10416) and the flexible PCB 10408 to couple the sensor10316 to the PCB 10408. In some embodiments, the third adhesivesubstrate 10424 c may also comprise a Z-axis anisotropic (or conductive)pressure-adhesive tape. In such embodiments, the third adhesivesubstrate 10424 c may also facilitate electrical communication betweenthe sensor contacts 10422 provided on the flag 10416 and thecorresponding circuitry contacts included on the PCB 10408. Coupling thecap 10404 and the sensor holder 10406 may help maintain sufficientpressure on the third adhesive substrate 10424 c to ensure reliableelectrical connection between the sensor 10316 and the PCB 10408. Eachof the adhesive substrates 320 a-c may also seal against liquid andmoisture, thus helping to mitigate the chances of shorting the sensor10316 and the PCB 10408.

Referring now to FIG. 104B, the sensor electronics module 10402 may besized to be received between the upper and lower covers 10306, 10308. Inthe illustrated embodiment, the upper cover 10306 provides or otherwisedefines a cavity that may receive the sensor electronics module 10402.In other embodiments, however, the lower cover 10308, or both the upperand lower covers 10306, 10308, could alternatively define the cavity,without departing from the scope of the disclosure.

The sensor control device 10302 may also include a filler 10426 that maybe arranged between the upper and lower covers 10306, 10308. In someembodiments, the filler 10426 may comprise foam made of a low-densitypolyethylene, polyolefin, or polyurethane. Moreover, the filler 10426may be die cut and/or molded to mate with the sensor electronics module10402. As illustrated, for instance, the filler 10426 may define anaperture 328 sized to receive a portion of the sensor electronics module10402 and, more particularly, the sensor holder 10406. In someembodiments, the filler 10426 may operate similar to a potting materialby taking up space within the electronics housing 10304 (FIG. 103) thatwould otherwise be occupied by air. Moreover, the material of the filler10426 may expand less than air at elevated altitudes, such as would beexperienced during shipping. The filler 10426 may also help to stabilizethe electrical components of the PCB 10408 (FIG. 104B) and mitigatevibration.

The sensor control device 10302 may further include a fourth adhesivesubstrate 10424 d, which may also comprise a pressure-adhesive tape thatforms a bond when pressure is applied. The fourth adhesive substrate10424 b may interpose the lower cover 10308 and the filler 10426, andmay operate to secure the filler 10426 to the lower cover 10308. Theadhesive substrates 10424 a-d may each be die-cut, thermoformed, orstamped pieces of material.

FIG. 105 is a cross-sectional side view of the assembled sensor controldevice 10302, according to one or more embodiments. Securing the upperand lower covers 10306, 10308 to one another, as described above,secures the sensor electronics module 10402 and the filler 10426 withinthe electronics housing 10304. Once the upper and lower covers 10306,10308 are secured, the plug assembly 10310 may be received by the sensorcontrol device 10302 by extending the sharp 10318 through theelectronics housing 10304 until the sharp hub 10320 engages a topsurface 10502 of the sensor control device 10302, such as a top surfaceof the cap 10404. As the sharp 10318 extends through the electronicshousing 10304, the sensor 10316 (e.g., the tail 10314) may be receivedwithin a hollow or recessed portion of the sharp 10318.

As described in more detail below, the sensor control device 10302 maybe manufactured via a converting process, where some parts of the sensorcontrol device 10302 are assembled or otherwise formed in a step-wisefashion from large rolls of material. As a result, the sensor controldevice 10302 may be entirely made at a factory, thus eliminating userassembly. Moreover, whereas current sensor control devices commonly useglues, potting, or casting and encapsulating compounds to seal andenclose (encapsulate) the sensor 10316 and the PCB 10408, fabricatingthe sensor control device 10302 using the presently disclosed convertingprocesses eliminates the need for glues or “wet chemistry,” thus makingthe fabrication process not dependent on curing methods or time.

FIG. 106 is an isometric view of another example sensor control device10602, according to one or more embodiments of the present disclosure.The sensor control device 10602 may be the same as or similar to thesensor control device 104 of FIG. 1 and, therefore, may be used inconjunction with the sensor applicator 102 (FIG. 1), which delivers thesensor control device 10602 to a target monitoring location on a user'sskin. Moreover, the sensor control device 10602 may be similar in somerespects to the sensor control device 10302 of FIGS. 103, 104A-104B and105 and therefore may be best understood with reference thereto, wherelike numerals will represent like components not described again indetail.

Similar to the sensor control device 10302 of FIGS. 103, 104A-104B and105, the sensor control device 10602 includes the electronics housing10304 made of the upper and lower covers 10306, 10308. The sensorcontrol device 10602 may further include the plug assembly 10310, thesensor module 10312 with the sensor 10316, and the sharp module 10314with the sharp 10318. Corresponding portions of the sensor 10316 and thesharp 10318 extend distally from the electronics housing 10304 and, moreparticularly, from the bottom of the lower cover 10308. Unlike thesensor control device 10302, however, one or both of the upper and lowercovers 10306, 10308 may be made of a rigid material such as, but notlimited to, a plastic, a metal, a composite material, a ceramic, or anycombination thereof. Alternatively, one or both of the upper and lowercovers 10306, 10308 can be made of a semi rigid or flexible materials,such as an elastomer.

FIGS. 107A and 107B are exploded, isometric views of the sensor controldevice 10602 of FIG. 106, according to one or more embodiments. Morespecifically, FIG. 107A is an exploded, isometric view of a sensorelectronics module 10702 included in the sensor control device 10602,and FIG. 107B is an exploded, isometric view of the sensor controldevice 10602 with the sensor electronics module 10702.

Referring first to FIG. 107A, the sensor electronics module 10702includes a sensor holder 10704, the sensor 10316, and a printed circuitboard (PCB) 10706, which may be similar in some respects to the PCB10408 of FIG. 104A. The sensor holder 10704 may be made of injectionmolded plastic, for example, and may be configured to secure the sensor10316 to the sensor electronics module 10702. To accomplish this, thesensor holder 10704 may be engageable and matable with the PCB 10706. Inthe illustrated embodiment, for example, the sensor holder 10704includes or defines one or more projections 107608 (three shown) sizedto be received within or mate with one or more corresponding holes 10710(three shown) defined on the PCB 10706. Mating the projections 107608with the holes 10710 may secure the sensor 10316 to the sensorelectronics module 10702, thus resulting in a solid structuralcomponent. In other embodiments, however, the projections 107608 mayalternatively be provided on the PCB 10706, and the sensor holder 10704may instead define the holes 10710, without departing from the scope ofthe disclosure.

The tail 10314 of the sensor 10316 may be configured to extend through achannel 10712 defined in the sensor holder 10704 and extend distallyfrom the sensor electronics module 10702. The sensor contacts 10422 ofthe flag 10416 may be configured to align with a corresponding number ofcircuitry contacts (not shown) included on the PCB 10706 that provideconductive communication between the sensor 10316 and correspondingelectronic components provided on the PCB 10706.

The sensor electronics module 10702 may further include one or moreadhesive substrates, shown as a first adhesive substrate 10714 a and asecond adhesive substrate 10714 b. Similar to the adhesive substrates10424 a-d of FIGS. 104A-104B, each adhesive substrate 10714 a,b maycomprise a pressure-adhesive tape that forms a bond when pressure isapplied, and may each be die-cut, thermoformed, or stamped pieces ofmaterial. The first adhesive substrate 10714 a may interpose the sensorholder 10704 and the sensor 10316 (i.e., the flag 10416) and may operateto secure the sensor 10316 to the sensor holder 10704. In someembodiments, the sensor holder 10704 may define a depression 10716 sizedto receive one or both of the first adhesive substrate 10714 a and theflag 10416.

The second adhesive substrate 10714 b may be configured to help attachthe sensor 10316 and the sensor holder 10704 to the PCB 10706. Moreover,the second adhesive substrate 10714 b may comprise a Z-axis anisotropic(or conductive) pressure-adhesive tape and may therefore also facilitateelectrical communication between the sensor contacts 10422 provided onthe flag 10416 with the corresponding circuitry contacts included on thePCB 10706. Coupling the sensor holder 10704 to the PCB 10706 may helpmaintain sufficient pressure on the second adhesive substrate 10714 b toensure reliable electrical contact between the sensor 10316 and the PCB10706. The adhesive substrates 10714 a,b may also seal against liquidand moisture, thus helping to mitigate the chances of shorting thesensor 10316 and the PCB 10706.

Referring now to FIG. 107B, the sensor electronics module 10702 may besized to be received between the upper and lower covers 10306, 10308. Inthe illustrated embodiment, the upper cover 10306 provides or otherwisedefines a cavity that can receive the sensor electronics module 10702.In other embodiments, however, the lower cover 10308, or a combinationof the upper and lower covers 10306, 10308, could alternatively definethe cavity, without departing from the scope of the disclosure. Thesensor control device 10602 may also include the filler 10426 arrangedbetween the upper and lower covers 10306, 10308 and defining theaperture 10428 sized to receive a portion of the sensor electronicsmodule 10702 and, more particularly, the sensor holder 10704.

FIG. 108 is a cross-sectional side view of the assembled sensor controldevice 10602, according to one or more embodiments. Securing the upperand lower covers 10306, 10308 to one another, as described herein,secures the sensor electronics module 10702 and the filler 10426 withinthe electronics housing 10304. Once the upper and lower covers 10306,10308 are secured and otherwise sealed, the plug assembly 10310 may bereceived by the sensor control device 10602 by extending the sharp 10318through the electronics housing 10304 until the sharp hub 10320 engagesa top surface 10802 of the sensor control device 10602, such as a topsurface of the upper cover 10306. As the sharp 10318 extends through theelectronics housing 10304, the sensor 10316 (e.g., the tail 10314) maybe received within a hollow or recessed portion of the sharp 10318.

FIG. 109 is an isometric view of an example converting process 10900 formanufacturing a sensor control device 10902 in accordance with theprinciples of the present disclosure. More specifically, the convertingprocess 10900 is depicted showing progressive, step-wise building of aweb-based assembly that results in the fabrication of the sensor controldevice 10902. The sensor control device 10902 may be the same as orsimilar to any of the sensor control devices 104, 10302, 10602 describedherein with reference to FIGS. 1, 103, and 106, respectively.Accordingly, any of the sensor control devices 104, 10302, 10602 may befabricated using the presently described converting process 10900.

Whereas current sensor control devices are commonly made of hardplastics and require use assembly, the sensor control device 10902 madeby the converting process 10900 may be made of flexible materials thatdo not require user assembly. Alternatively, rigid materials may insteadbe incorporated, without departing from the scope of the disclosure. Theconverting process 10900 may incorporate the use of one or morecontinuous rolls of process materials, such as a base substrate 10904that may eventually form the lower cover 10308 (FIGS. 103 and 106) ofthe electronics housing 10304 (FIGS. 103 and 106). The base substrate10904 may be continuously unrolled (unwound) from an adjacent roll (notshown) of material. This web-based process may include or exclude theincorporate of injection molded parts, such as for the upper or lowercovers 10306, 10308. Consequently, fabrication of sensor control devices(e.g., the sensor control device 10902) using the converting process10900 may proceed in a continuous process that progressively modifiesand/or arranges the materials and component parts to form the sensorcontrol devices 10902.

FIGS. 110A-110E are referenced in FIG. 109 and depict progressivefabrication of the sensor control device 10902, according to one or moreembodiments. FIGS. 110A-110E will be described below to detail thevarious steps of the example converting process 10900.

Referring first to FIG. 110A, in a first step of the process 10900, ahole 11002 may be punched or otherwise formed in the base substrate10904, which may comprise a sheet of material that may eventually formthe base or lower cover 10308 (FIGS. 103 and 106) of the sensor controldevice 10902 (FIG. 109). The base substrate 10904 may comprise a belt orthin film made of a variety of different materials including, but notlimited to, a plastic, a metal, a composite material, or any combinationthereof. In at least one embodiment, the base substrate 10904 maycomprise a laminated aluminum foil having a polyester film on one side(e.g., the bottom side), and a polyolefin heat seal layer on theopposing side (e.g., the top side).

In a second step of the process 10900, a sensor holder 11004 may becoupled to the base substrate 10904. The sensor holder 11004 may be thesame as or similar to either of the sensor holders 10406, 10704 of FIGS.104A and 107A, respectively. Accordingly, the sensor holder 11004 maydefine a channel 11006 sized to receive the tail 10314 (FIGS. 104A and107A) of the sensor 10316 (FIGS. 104A and 107A). In some embodiments,the sensor holder 11004 may be ultrasonically welded or heat-sealed tothe base substrate 10904, thus resulting in a sealed and watertightengagement. In at least one embodiment, however, the base substrate10904 may comprise or otherwise include an adhesive substrate on the topside to secure and seal the sensor holder in place.

In a third step of the process 10900, a first adhesive substrate 11008 amay be attached to the top of the sensor holder 11004. The firstadhesive substrate 11008 a may be similar to any of the adhesivesubstrates 10424 a-d (FIGS. 104A-104B), 10714 a,b (FIGS. 107A-107B)described herein, and may thus comprise a pressure-adhesive tape thatforms a bond when pressure is applied. In at least one embodiment, thefirst adhesive substrate 11008 a may comprise double-sided polyolefinfoam tape and may be pressure sensitive on both sides.

In a fourth step of the process 10900, the sensor 10316 may be securedto the sensor holder 11004 using the first adhesive substrate 11008 a.More specifically, the tail 10314 (FIGS. 104A and 107A) may be extendedthrough the channel 11006 and the flag 10416 may be bent generallyorthogonal to the tail 10314 and coupled to the underlying firstadhesive substrate 11008 a.

Referring now to FIG. 110B, in a fifth step of the process 10900, aprinted circuit board (PCB) 11010 may be positioned on the basesubstrate 10904 and about the sensor holder 11004. The PCB 11010 may besimilar in some respects to the PCB 10408 of FIGS. 104A and 107A, andmay thus include a plurality of electronic modules 11012 mountedthereto. The electronic modules 11012 may include one or both of aBluetooth antenna and a near field communication (NFC) antenna. Asillustrated, the PCB 11010 may define two opposing lobes 11014 a and11014 b interconnected by a neck portion 11016. Opposing batterycontacts 11018 a and 11018 b may be provided on the opposing lobes 11014a,b to facilitate electrical communication with a battery 11020.

In a sixth step of the process 10900, a second adhesive substrate 11008b may be applied to the first battery contact 11018 a in preparation forreceiving the battery 11020 in an adjacent seventh step of the process10900. The second adhesive substrate 11008 b may comprise apressure-adhesive tape used to couple the battery 11020 to the firstbattery contact 11018 a. The second adhesive substrate 11008 b, however,may also comprise a Z-axis anisotropic (or conductive) pressure-adhesivetape that also facilitates electrical communication (i.e., transfer ofelectrical power) between the battery 11020 and the first batterycontact 11018 a.

Referring now to FIG. 110C, in an eighth step of the process 10900, afiller 11022 may be positioned or arranged on the first lobe 11014 a ofthe PCB 11010. The filler 11022 may be the same as or similar to thefiller 10426 of FIG. 104B or 107B, and may thus comprise foam made of alow-density polyethylene or polyolefin. Moreover, the filler 11022 maybe die cut and/or molded to fit around one or both of the battery 11020and the sensor holder 11004. In the illustrated embodiment, the filler11022 may define apertures 11024 a and 11024 b to receive the battery11020 and/or the sensor holder 11004. The filler 11022 may also operateas a potting material that takes up space that would otherwise beoccupied by air, and thus help to stabilize the electronic modules 11012(FIG. 110B) of the PCB 11010 and mitigate damaging vibration.

In a ninth step of the process 10900, a third adhesive substrate 11008 cmay be applied to a top of the filler 11022 to help couple the secondlobe 11014 b of the PCB 11010 to the top of the filler 11022 in asubsequent step of the process 10900. The third adhesive substrate 11008c may comprise a pressure-adhesive tape, but may also comprise a Z-axisanisotropic (or conductive) pressure-adhesive tape that also facilitateselectrical communication (i.e., transfer of electrical power) betweenthe battery 11020 and the second battery contact 11018 b. The thirdadhesive substrate 11008 c may also facilitate electrical communicationbetween the sensor contacts 10422 provided on the sensor 10316 andcorresponding circuitry contacts 11026 (three shown) included on the PCB11010.

Referring now to FIG. 110D, in a tenth step of the process 10900, thesecond lobe 11014 b of the PCB 11010 may be folded down at the neck11016 to couple the PCB 11010 to the filler 11022. Coupling the PCB11010 to the filler 11022 may also complete the conductive pathway viathe third adhesive substrate 11008 c between the battery 11020 and thesecond battery contact 11018 b, and between the sensor contacts 10422and the corresponding circuitry contacts 11026.

In an eleventh step of the process 10900, a fourth adhesive substrate11008 d may be applied to a portion of the top of the second lobe 11014b of the PCB 11010. The fourth adhesive substrate 11008 d may alsocomprise a pressure-adhesive tape, and may be used to couple an uppercover 11028 to the PCB 11010, as provided in a twelfth step of theprocess 10900. The upper cover 11028 may be the same as or similar tothe upper cover 10306 of FIGS. 103 and 106, and the fourth adhesivesubstrate 11008 d may help secure the upper cover 10306 to the PCB11010.

In some embodiments, the upper cover 11028 may be provided by anotherroll of material continuously provided to the web-based assembly in theprocess 10900. In some embodiments, the upper cover 11028 may bevacuum-formed, but could alternatively, be cold formed or injectionmolded, without departing from the scope of the disclosure. Accordingly,as indicated above, this web-based process 10900 may include or excludeinjection molded parts, such as for the upper or lower covers 10306,10308. In some embodiments, the upper cover 11028 may be formed ordefined to provide a flange 11030 about its periphery, and the flange11030 may provide a location to seal the upper cover 11028 to the basesubstrate 10904 (i.e., the “lower cover”). The upper cover 11028 may besecured to the base substrate 10904 via one or more of sonic welding,ultrasonic welding, laser welding, photonic flash soldering, heatsealing, an adhesive substrate (e.g., a pressure sensitive adhesive ortape), or any combination thereof. Alternatively, the fourth adhesivesubstrate 11008 d may sufficiently couple the upper cover 11028 to thebase substrate 10904, or an additional adhesive substrate (not shown)may be applied at the flange 11030 to secure the upper cover 11028 tothe base substrate 10904, without departing from the scope of thedisclosure.

Referring now to FIG. 110E, in a thirteenth step of the process 10900,the outer diameter of the sensor control device 10902 may be trimmed toremove the excess portions of the base substrate 10904 (FIGS. 110A and110D). In some embodiments, as illustrated, the sensor control device10902 may have a substantially circular cross-section, but couldalternatively comprise any other cross-sectional shape, such aspolygonal, oval, ovoid (e.g., pill- or egg-shaped), a squircle, or anycombination thereof, without departing from the scope of the disclosure.

In a fourteenth and final step of the process 10900, the plug assembly10310 as described herein may be received by the sensor control device10902 by extending the sharp 10318 through the sensor control device10902 until the sharp hub 10320 engages a top surface of the sensorcontrol device 10902. As the sharp 10318 extends through the sensorcontrol device 10902, the sensor 10316 may be received within a hollowor recessed portion of the sharp 10318.

FIG. 111A is a top view of the sensor control device 10902 inpreparation for pressure testing and/or vacuum sealing, according to oneor more embodiments. In the illustrated embodiment, a web 11102 may formpart of or otherwise extend from the sensor control device 10902 acrossa tab section 11104. The tab section 11104 may form part of the flange11030 or may otherwise extend therefrom. The web 11102 may comprise twolayers of film 11106 a and 11106 b. In some embodiments, for instance,the upper layer 11106 a may be connected to or form part of the materialthat forms the upper cover 11028, as described above with reference toFIGS. 110D and 110E, and the lower layer 11106 b may be connected to orform part of the base material 10904, as described above with referenceto FIGS. 109, 110A and 110D.

An aperture 11108 may be defined through the upper layer 11106 a (or thelower layer 11106 b) to facilitate fluid communication between the twolayers 11106 a,b and the interior of the sensor control device 10902. Aseal 11110 may be made about the periphery of the web 11102 to seal theupper and lower layers 11106 a,b together. Moreover, the flange 11030may be sealed about the periphery of the sensor control device 10902except across the tab section 11104, thus facilitating fluidcommunication into and/or out of the sensor control device via the web11102. In some embodiments, one or both of the upper and lower layers11106 a,b may provide or otherwise define a pattern or web ofinterconnected channels 11112 that help facilitate fluid communicationbetween the aperture 11108 and the interior of the sensor control device10902 via the tab section 11104.

By injecting air (or another fluid) into the sensor control device 10902via the aperture 11108 and the web 11102, the sensor control device10902 may be pressure tested to determine if the outer periphery (e.g.,the flange 11030) or other portions of the sensor control device 10902are properly sealed. This is often referred to as “pressure decaytesting,” and helps verify seal integrity of medical devices made oflayers of film. Alternatively, air may be evacuated from the sensorcontrol device 10902 via the aperture 11108 and the web 11102 to placethe interior of the sensor control device 10902 under vacuum conditions.The channels 11112 may prove advantageous in helping to draw the vacuumwithout entirely collapsing the upper and lower layers 11106 a,b.

FIG. 111B is a cross-sectional side view of the sensor control device10902 with a compressor 11114. The compressor 11114 may have properfittings to fluidly couple to the web 11102 via the aperture 11108. Insome embodiments, the compressor 11114 may be arranged on a back support11116 to help support the pressure fitting at the aperture 11108.

To pressure test the sensor control device 10902 to determine if itmeets pressure requirements, the compressor 11114 may inject air intothe web 11102 via the aperture 11108, and the air may circulate to theinterior of the sensor control device 10902 between the opposing layers11106 a,b and via the tab section 11104. This allows seal integritytesting to be performed during the manufacturing process of the sensorcontrol device 10902. Once the seal integrity is verified, the peripheryof the sensor control device 10902 at the tab section 11104 may besealed and the web 11102 may be trimmed from the sensor control device10902.

In some embodiments, after the sensor control device 10902 has beenpressure tested, operation of the compressor 11114 may be reversed topull a vacuum on the sensor control device 10902, as indicated above.Once the vacuum is drawn, the periphery of the sensor control device10902 at the tab section 11104 may be sealed, thus leaving the sensorcontrol device 10902 under vacuum conditions. As will be appreciated,vacuum conditions may prove advantageous since the sensor control device10902 may be transported through high altitudes, where a non-vacuumsealed device would have a tendency to expand or “pillow” out. Moreover,the vacuum may be drawn during the manufacturing process, followingwhich the web 11102 may be trimmed from the sensor control device 10902.

FIG. 112 is a partial cross-sectional side view of an example sensorcontrol device 11200, according to one or more embodiments. The sensorcontrol device 11200 may be similar in some respects to any of thesensor control devices described herein. As illustrated, the sensorcontrol device 11200 may include a housing 11202 configured to houseelectronic modules or components used to operate the sensor controldevice. Example electronic modules include, but are not limited to abattery, a data processing unit (e.g., an application specificintegrated circuit or ASIC), a resistor, a transistor, a capacitor, aninductor, a diode, and a switch.

The sensor control device 11200 may further include a sensor 11204 and asharp 11206, which may be similar to any of the sensors and sharpsdescribed herein. Consequently, the sharp 11206 may be used to helptranscutaneously implant the sensor 11204 beneath a user's skin formonitoring blood glucose levels. In the illustrated embodiment, thesensor 11204 and the sharp 11206 are arranged within a sterile chamber11208 to protect the sensor 11204 and the sharp 11206 from externalcontamination. In some embodiments, the sterile chamber 11208 may have adesiccant arranged therein to help promote preferred humidityconditions.

In some embodiments, the sensor 11204 and the sharp 11206 may besterilized while assembled within the sensor control device 11200. In atleast one embodiment, the sensor 11204 and the sharp 11206 may besubjected to radiation sterilization to properly sterilize the sensor11204 and the sharp 11206 for use. Suitable radiation sterilizationprocesses include, but are not limited to, electron beam (e-beam)irradiation, gamma ray irradiation, X-ray irradiation, or anycombination thereof.

In some embodiments, the sterile chamber 11208 may comprise a cap thatprovides a sealed barrier that protects exposed portions of the sensor11204 and the sharp 11206 until placed in use. In such embodiments, thesterile chamber 11208 may be removable or detachable to expose thesensor 11204 and the sharp 11206, as described below. Moreover, in suchembodiments, the cap may be made of a material that permits propagationof radiation therethrough to facilitate radiation sterilization of thesensor 11204 and the sharp 11206. Suitable materials for the sterilechamber 11208 include, but are not limited to, a non-magnetic metal(e.g., aluminum, copper, gold, silver, etc.), a thermoplastic, ceramic,rubber (e.g., ebonite), a composite material (e.g., fiberglass, carbonfiber reinforced polymer, etc.), an epoxy, or any combination thereof.In some embodiments, the sterile chamber 11208 may be transparent ortranslucent, but can otherwise be opaque, without departing from thescope of the disclosure.

In other embodiments, the sterile chamber 11208 may comprise a chamberor compartment defined within the sensor control device 11200. In suchembodiments, the sterile chamber 11208 may include a microbial barrierpositioned at one or both ends of the sterile chamber 11208. Morespecifically, the sterile chamber 11208 may provide or include an uppermicrobial barrier 11210 a and a lower microbial barrier 11210 b oppositethe upper microbial barrier 11210 a. The upper and lower microbialbarriers 11210 a,b may help seal the sterile chamber 11208 to therebyisolate the sensor 11204 and the sharp 11206 from externalcontamination. The microbial barriers 11210 a,b may be made of aradiation permeable material, such as a synthetic material (e.g., aflash-spun high-density polyethylene fiber). One example syntheticmaterial comprises TYVEK®, available from DuPont®. In other embodiments,however, the microbial barriers 11210 a,b may comprise, but are notlimited to, tape, paper, film, foil, or any combination thereof.

In some embodiments, the sensor 11204 and the sharp 11206 may bedeployable and otherwise movable relative to the sensor control device11200. In such embodiments, the sensor 11204 and the sharp 11206 may beadvanced distally out of the sterile chamber 11208 and past the bottomof the housing 11202 to allow the sensor 11204 and the sharp 11206 to betranscutaneously received beneath a user's skin. Distally advancing thesensor 11204 and the sharp 11206 may be accomplished via a variety ofmechanical or electromechancial means. In some embodiments, for example,the sensor control device 11200 may include a pusher 11212 configured toadvance to push the sensor 11204 and the sharp 11206 out of the sterilechamber 11208. In such embodiments, the pusher 11212 may also beconfigured to attach to the sharp 11206 and subsequently retract thesharp 11206 while leaving the sensor 11204 extended. During operation,the pusher 11212 may penetrate the upper microbial barrier 11210 a andforce the sensor 11204 and the sharp 11206 distally through the lowermicrobial barrier 11210 b.

As illustrated, the pusher 11212 may comprise a flexible shaft thatextends within a curved pathway 11214 defined laterally through thehousing 11202 and does not penetrate the top of the housing 11202. Thepathway 11214 may terminate at or near an upper end of the sterilechamber 11208. In at least one embodiment, as illustrated, the pusher11212 may extend out of the housing 11202 at a sidewall 11216 thereof.In such embodiments, actuation of the pusher 11212 may originate at thelocation of the sidewall 11216 to advance or retract the pusher 11212within the pathway 11214 and thereby act on the sterile chamber 11208and/or the sensor 11204, and the sharp 11206.

In embodiments where the sterile chamber 11208 comprises a cap, thepusher 11212 may be operable to discharge or push the cap out of thesensor control device 11200. In such embodiments, a user may commencethe firing process by priming the sensor control device 11200, which maycause the cap to be discharged from the sensor control device 11200.Further actuation of the sensor control device 11200 by the user maycause the sensor 11204 and the sharp 11206 to be fully extended forsubcutaneous implantation. In other embodiments, the cap may be removedeither autonomously (e.g., it falls off or breaks away during firing) orthe user may manually remove it by hand.

FIG. 113 is a cross-sectional side view of an example sensor applicator11300, according to one or more embodiments. The sensor applicator 11300may be similar in some respects to any of the sensor applicatorsdescribed herein. Accordingly, the sensor applicator 11300 may beconfigured to house a sensor control device 11302 and may be operable todeploy the sensor control device 11302 to a target monitoring location.The sensor control device 11302 may be similar in some respects to anyof the sensor control devices described herein. As illustrated, thesensor control device 11302 may include an electronics housing 11304configured to house electronic modules or components used to operate thesensor control device 11302. The sensor control device 11302 may furtherinclude a sensor 11306 and a sharp 11308, which may be similar to any ofthe sensors and sharps described herein. Consequently, the sharp 11308may be used to help transcutaneously implant the sensor 11306 beneath auser's skin for monitoring blood glucose levels.

In the illustrated embodiment, the sensor applicator includes a housing11310 and an applicator cap 11312 removably coupled to the housing11310. The applicator cap 11312 may be threaded to the housing 11310 andmay be removed by rotating (e.g., unscrewing) the applicator cap 11312relative to the housing 11310.

In the illustrated embodiment, the sensor applicator 11300 may include afiller 11314 arranged at least partially within the applicator cap11312. In some embodiments, the filler 11314 may form an integral partor extension of the applicator cap 11312, such as being molded with orovermolded onto the applicator cap 11312. In other embodiments, thefiller 11314 may comprise a separate structure fitted within or attachedto the applicator cap 11312, without departing from the scope of thedisclosure. In some embodiments, the filler 11314 may generally helpsupport the sensor control device 11302 while contained within thesensor applicator 11302.

The filler 11314 may define or otherwise provide a sterilization zone11316 configured to receive the sensor 11306 and the sharp 11308 asextending from the bottom of the electronics housing 11304. Thesterilization zone 11316 may generally comprise a hole or passagewayextending at least partially through the body of the filler 11314. Whenthe sensor control device 11302 is loaded into the sensor applicator11302 and the applicator cap 11312 is secured thereto, the sensor 11306and the sharp 11308 may be positioned within the sterilization zone11316 of the filler 11314, which may be sealed to isolate the sensor11306 and the sharp 11308 from external contamination.

The applicator cap 11312 and the filler 11314 may each be made of a gasimpermeable material, such as a plastic or polycarbonate. Moreover, agasket 11318 may be located at an interface between the filler 11314 andthe bottom of the electronics housing 11304 to generate a gas-tightseal. In some embodiments, the gasket 11318 may be overmolded onto thefiller 11314 or alternatively onto the bottom of the electronics housing11304. In other embodiments, however, the gasket 11318 may comprise aseparate component part or seal, such as an O-ring or the like.

While the sensor control device 11302 is positioned within the sensorapplicator 11302, the sensor 11306 and the sharp 11308 may besterilized. According to the present embodiment, sterilizing the sensor11306 and the sharp 11308 may be accomplished by introducing asterilizing gas 11320 into the sterilization zone 11316. The sterilizinggas 11320 may comprise, for example, nitrogen dioxide (NO₂), whichoperates to sterilize the sensor 11306 and the sharp 11308 withoutadversely affecting the chemistry on the sensor 11306. Moreover, thegasket 11318 may prevent the sterilizing gas 11320 from migratinglaterally out of the sterilization zone 11316 and impinging upon anddamaging an adhesive layer 11322 attached to the bottom of theelectronics housing 11304. Accordingly, the sterilization zone 11316allows transmission of the sterilizing gas 11320 to impinge upon andsterilize the sensor 11306 and the sharp 11308, while the remainingportions of the filler 11314 and the gasket 11318 prevent (impede) thesterilizing gas 11320 from damaging the integrity of the adhesive layer11322.

In some embodiments, a microbial barrier 11324 may be applied to the endof the filler 11314 and/or the applicator cap 11312 to seal off thesterilization zone 11316. In some embodiments, the microbial barrier11324 may comprise two or more layers of different materials. The firstlayer may be made of a synthetic material (e.g., a flash-spunhigh-density polyethylene fiber), such as Tyvek® available from DuPont®.Tyvek® is highly durable and puncture resistant and allows thepermeation of vapors and gases. The Tyvek® layer can be applied beforeor after application of the sterilizing gas 11320, and following thesterilizing process, a foil or other vapor and moisture resistantmaterial layer may be sealed (e.g., heat sealed) over the Tyvek® layerto prevent the ingress of contaminants and moisture into thesterilization zone 11316. In other embodiments, the microbial barrier11324 may comprise only a single protective layer applied to the end ofthe filler 11314. In such embodiments, the single layer is gas permeablefor the sterilization process, but is also capable of protection againstmoisture and other harmful elements once the sterilization process iscomplete. Accordingly, the microbial barrier 11324 may operate as amoisture and contaminant layer, without departing from the scope of thedisclosure.

It is noted that, while the sensor 11306 and the sharp 11308 extend fromthe bottom of the electronics housing 11304 and into the sterilizationzone 11316 generally concentric with a centerline of the sensorapplicator 11302 and the applicator cap 11312, it is contemplated hereinto have an eccentric arrangement. More specifically, in at least oneembodiment, the sensor 11306 and the sharp 11308 may extend from thebottom of the electronics housing 11304 eccentric to the centerline ofthe sensor applicator 11302 and the applicator cap 11312. In suchembodiments, the filler 11314 may be re-designed and otherwiseconfigured such that the sterilization zone 11316 is also eccentricallypositioned to receive the sensor 11306 and the sharp 11308, withoutdeparting from the scope of the disclosure.

Embodiments disclosed herein include:

HH. A sensor control device that includes an electronics housingincluding an upper cover securable to a lower cover, a sensorelectronics module positionable between the upper and lower covers andincluding a sensor holder defining a channel, a sensor including a tailextendable through the channel and a flag that includes one or moresensor contacts, a printed circuit board (PCB) having one or morecircuitry contacts alignable with the one or more sensor contacts, afirst adhesive substrate interposing the flag and the sensor holder tosecure the sensor to the sensor holder, and a second adhesive substrateinterposing the flag and the PCB to secure the sensor to the PCB andfacilitate electrical communication between the one or more sensorcontacts and the one or more circuitry contacts. The sensor controldevice further includes a sharp extendable through the electronicshousing, wherein the sharp and the tail extend from a bottom of theelectronics housing.

II. A converting process of fabricating a sensor control device thatincludes positioning a sensor holder defining a channel on a basesubstrate, extending a tail of a sensor through the channel and securinga flag of the sensor to the sensor holder with a first adhesivesubstrate applied to a top of the sensor holder, wherein the flagincludes one or more sensor contacts, positioning a printed circuitboard (PCB) on the base substrate and about the sensor holder, the PCBproviding one or more circuitry contacts alignable with the one or moresensor contacts, attaching the PCB to the flag with a second adhesivesubstrate applied to a top of the flag, facilitating electricalcommunication between the one or more sensor contacts and the one ormore circuitry contacts with the second adhesive substrate, positioningan upper cover over the PCB and securing the upper cover to the basesubstrate to form an electronics housing, trimming the base substrateabout an outer periphery of the electronics housing, and extending asharp through the electronics housing, wherein the sharp and the tailextend from a bottom of the electronics housing.

Each of embodiments HH and II may have one or more of the followingadditional elements in any combination: Element 1: further comprising afiller positionable between the upper and lower covers with the sensorelectronics module. Element 2: further comprising a third adhesivesubstrate interposing the lower cover and the filler to secure thefiller to the lower cover. Element 3: wherein the sensor electronicsmodule further includes a cap matable with the sensor holder to helpsecure the sensor within the sensor electronics module. Element 4:wherein the sensor electronics module further includes a third adhesivesubstrate interposing the cap and the PCB to secure the cap to the PCB.Element 5: wherein the sensor holder is matable with the PCB. Element 6:wherein one or both of the upper and lower covers are made of a materialselected from the group consisting of a film, a foil, a foam, alaminated material, and any combination thereof. Element 7: wherein oneor both of the upper and lower covers are formed by a manufacturingprocess selected from the group consisting of thermoforming, vacuumforming, injection molding, die-cutting, stamping, compression molding,transfer molding, and any combination thereof. Element 8: wherein theupper cover is secured to the lower cover via at least one of sonicwelding, ultrasonic welding, laser welding, heat sealing, an adhesivesubstrate, and any combination thereof.

Element 9: wherein the base substrate comprises a film of materialdisposed on a roll, and attaching the sensor holder to the basesubstrate is preceded by unrolling the base substrate from the roll, andforming a hole in the base substrate. Element 10: wherein positioningthe sensor holder on the base substrate comprises securing the sensorholder to the base substrate using at least one of ultrasonic welding,heat sealing, an adhesive substrate, and any combination thereof.Element 11: wherein the PCB defines first and second lobesinterconnected by a neck portion and the one or more circuitry contactsare provided on the second lobe, and wherein attaching the PCB to theflag comprises folding the second lobe onto the first lobe at the neckportion, and aligning the one or more circuitry contacts with the one ormore sensor contacts. Element 12: wherein each lobe provides a batterycontact, and the method further comprises applying a third adhesivesubstrate to the battery contact on the first lobe, attaching a batteryto the third adhesive substrate, wherein the second adhesive substrateis further applied to a top of the battery, and folding the second lobeonto the first lobe to align the battery contact on the second lobe withthe top of the battery, wherein the second and third adhesive substratescomprise Z-axis anisotropic pressure-adhesive tapes that facilitateelectrical communication between the battery and the battery contacts.Element 13: further comprising positioning a filler on the PCB and aboutthe sensor holder, and mitigating vibration and stabilizing electronicmodules of the PCB with the filler. Element 14: further comprisingapplying a third adhesive substrate between the PCB and the upper coverto secure the upper cover to the PCB. Element 15: wherein positioningthe upper cover over the PCB comprises forming the upper cover using aprocess selected from the group consisting of thermoforming, coldforming, vacuum forming, injection molding, die-cutting, stamping, andany combination thereof. Element 16: wherein securing the upper cover tothe base substrate comprises sealing the upper cover to the basesubstrate using a process selected from the group consisting of sonicwelding, ultrasonic welding, laser welding, heat sealing, using anadhesive substrate, and any combination thereof. Element 17: furthercomprising forming a web extending from the outer periphery of theelectronics housing and across a tab section, the web providing upperand lower layers sealed at a periphery, facilitating fluid communicationinto an interior of the electronics housing via the web and an aperturedefined in the upper layer, and pressure testing the electronics housingby injecting air into the electronics housing via the aperture and theweb. Element 18: further comprising extracting air from the interior ofthe electronics housing via the web and the aperture, and sealing theouter periphery of the electronics housing under vacuum conditions.

By way of non-limiting example, exemplary combinations applicable to HHand II include: Element 1 with Element 2; Element 3 with Element 4;Element 11 with Element 12; and Element 17 with Element 18.

Example Embodiments of Sensor Module and Plug

FIGS. 114A and 114B are top and bottom perspective views, respectively,of an example embodiment of the plug 2702 of FIGS. 27A-27B, according toone or more embodiments. As described above, the plug 2702 may bedesigned to hold the connector 2704 (FIGS. FIGS. 27A-27B and 115A-115B)and the sensor 2616 (FIGS. 27B and 116). The plug 2702 is capable ofbeing securely coupled with the electronics housing 2604 (FIGS.26A-26B), and the deflectable arms 2707 are configured to snap intocorresponding features provided on the bottom of the electronics housing2604. The sharp slot 2706 can provide a location for the sharp tip 2726(FIG. 27B) to pass through and the sharp shaft 2724 (FIGS. 27A-27B) totemporarily reside. As illustrated, a sensor ledge 11402 can define asensor position in a horizontal plane, prevent a sensor from lifting theconnector 2704 off of connector posts 11404 and maintain the sensor 2616parallel to a plane of connector seals. It can also define sensor bendgeometry and minimum bend radius. It can limit sensor travel in avertical direction and prevent a tower from protruding above anelectronics housing surface and define a sensor tail length below apatch surface. A sensor wall 11406 can constrain the sensor 2616 anddefine a sensor bend geometry and minimum bend radius.

FIGS. 115A and 115B are perspective views depicting an exampleembodiment of the connector 2704 in open and closed states,respectively. The connector 2704 can be made of silicone rubber thatencapsulates compliant carbon impregnated polymer modules that serve asthe electrical conductive contacts 2720 between the sensor 2616 (FIGS.27B and 116) and electrical circuitry contacts for the electronicswithin housing 2604. The connector 2704 can also serve as a moisturebarrier for the sensor 2616 when assembled in a compressed state aftertransfer from a container to an applicator and after application to auser's skin. A plurality of seal surfaces 11502 can provide a watertightseal for electrical contacts and sensor contacts. The hinges 2718connect two distal and proximal portions of the connector 2704.

FIG. 116 is a perspective view of an example embodiment of the sensor2616. The neck 2712 can be a zone which allows folding of the sensor2616, for example ninety degrees. A membrane on the tail 2708 can coveran active analyte sensing element of the sensor 2616. The tail 2708 canbe the portion of the sensor 2616 that resides under a user's skin afterinsertion. The flag 2710 includes the contacts 2714 and also provides asealing surface. A biasing tower 11602 can be a tab that biases the tail2708 into the sharp slot 2706 (FIGS. 114A-114B). A bias fulcrum 11604can be an offshoot of the biasing tower 11602 that contacts an innersurface of a needle to bias the tail 2708 into a slot defined by thesharp. A bias adjuster 11606 can reduce a localized bending of a tailconnection and prevent sensor trace damage. The contacts 2714 canelectrically couple the active portion of the sensor to the connector2704, and a service loop 11608 can translate an electrical path from avertical direction ninety degrees and engage with the sensor ledge 11402(FIG. 114B).

FIGS. 117A and 117B are bottom and top perspective views, respectively,depicting an example embodiment of a sensor module assembly comprisingthe sensor plug 2702, the connector 2704, and the sensor 2616. Accordingto one aspect of the aforementioned embodiments, during or afterinsertion, the sensor 2616 can be subject to axial forces pushing up ina proximal direction against the sensor 2616 and into the sensor module,as shown by force F1 of FIG. 15A. According to some embodiments, thiscan result in an adverse force F2 being applied to neck 2712 of thesensor 2616 and, consequently, result in adverse forces F3 beingtranslated to service loop 11608 of the sensor 2616. In someembodiments, for example, axial forces F1 can occur as a result of asensor insertion mechanism in which the sensor is designed to pushitself through the tissue, a sharp retraction mechanism duringinsertion, or due to a physiological reaction created by tissuesurrounding sensor 2616 (e.g., after insertion).

FIGS. 118A and 118B are close-up partial views of an example embodimentof the sensor plug 2702 having certain axial stiffening features. In ageneral sense, the embodiments described herein are directed tomitigating the effects of axial forces on the sensor 2616 as a result ofinsertion and/or retraction mechanisms, or from a physiological reactionto the sensor in the body. As illustrated, the sensor 2616 comprises aproximal portion having a hook feature 11802 configured to engage acatch feature 11804 of the plug 2702. In some embodiments, the plug 2702can also include a clearance area 11806 to allow a distal portion of thesensor 2616 to swing backwards during assembly to allow for the assemblyof the hook feature 11802 of the sensor 2616 over and into the catchfeature 11804 of the plug 2702.

According to another aspect of the embodiments, the hook and catchfeatures 11802, 11084 operate in the following manner. The sensor 2616includes a proximal sensor portion, coupled to the plug 2702, asdescribed above, and a distal sensor portion that is positioned beneatha skin surface in contact with a bodily fluid. The proximal sensorportion may include the hook feature 11802 adjacent to the catch feature11804 of the plug 2702. During or after sensor insertion, one or moreforces are exerted in a proximal direction along a longitudinal axis ofthe sensor 2616. In response to the one or more forces, the hook feature11802 engages the catch feature 11804 to prevent displacement of thesensor 2616 in a proximal direction along the longitudinal axis.

According to another aspect of the disclosure, the sensor 2616 can beassembled with the plug 2702 in the following manner. The sensor 2616 isloaded into the plug 2702 by displacing the proximal sensor portion in alateral direction to bring the hook feature 11802 in proximity to thecatch feature 11804 of the plug 2702. More specifically, displacing theproximal sensor portion in a lateral direction causes the proximalsensor portion to move into the clearance area 11806 of the plug 2702.

Although FIGS. 118A and 118B depict the hook feature 11802 as a part ofthe sensor 2616, and the catch feature 11804 as a part of the plug 2702,those of skill in the art will appreciate that the hook feature 11802can instead be a part of the plug 2702, and, likewise, the catch feature11804 can instead be a part of the sensor 3106. Similarly, those ofskill in the art will also recognize that other mechanisms (e.g.,detent, latch, fastener, screw, etc.) implemented on the sensor 2616 andthe plug 2702 to prevent axial displacement of sensor 2616 are possibleand within the scope of the present disclosure.

FIG. 119 is a side view of an example sensor 11900, according to one ormore embodiments of the disclosure. The sensor 11900 may be similar insome respects to any of the sensors described herein and, therefore, maybe used in an analyte monitoring system to detect specific analyteconcentrations. As illustrated, the sensor 11900 includes a tail 11902,a flag 11904, and a neck 11906 that interconnects the tail 11902 and theflag 11904. The tail 11902 includes an enzyme or other chemistry orbiologic and, in some embodiments, a membrane may cover the chemistry.In use, the tail 11902 is transcutaneously received beneath a user'sskin, and the chemistry included thereon helps facilitate analytemonitoring in the presence of bodily fluids.

The tail 11902 may be received within a hollow or recessed portion(e.g., the recessed portion 2728 of FIG. 27B) of a sharp (not shown) toat least partially circumscribe the tail 11902 of the sensor 11900. Asillustrated, the tail 11902 may extend at an angle Θ offset fromhorizontal. In some embodiments, the angle Θ may be about 85°.Accordingly, in contrast to other sensor tails, the tail 11902 may notextend perpendicularly from the flag 11904, but instead at an angleoffset from perpendicular. This may prove advantageous in helpingmaintain the tail 11902 within the keep the recessed portion of thesharp.

The tail 11902 includes a first or bottom end 11908 a and a second ortop end 11908 b opposite the top end 11908 a. A tower 11910 may beprovided at or near the top end 11908 b and may extend vertically upwardfrom the location where the neck 11906 interconnects the tail 11902 tothe flag 11904. During operation, if the sharp moves laterally, thetower 11910 will help picot the tail 11902 toward the sharp andotherwise stay within the recessed portion (e.g., the recessed portion2728 of FIG. 27B) of the sharp. Moreover, in some embodiments, the tower11910 may provide or otherwise define a protrusion 11912 that extendslaterally therefrom. When the sensor 11900 is mated with the sharp andthe tail 11902 extends within the recessed portion of the sharp, theprotrusion 11912 may engage the inner surface of the recessed portion.In operation, the protrusion 11912 may help keep the tail 11902 withinthe recessed portion.

The flag 11904 may comprise a generally planar surface having one ormore sensor contacts 11914 arranged thereon. The sensor contact(s) 11914may be configured to align with a corresponding number of compliantcarbon impregnated polymer modules encapsulated within a connector.

In some embodiments, as illustrated, the neck 11906 may provide orotherwise define a dip or bend 11916 extending between the flag 11904and the tail 11902. The bend 11916 may prove advantageous in addingflexibility to the sensor 11900 and helping prevent bending of the neck11906.

In some embodiments, a notch 11918 (shown in dashed lines) mayoptionally be defined in the flag near the neck 11906. The notch 11918may add flexibility and tolerance to the sensor 11900 as the sensor11900 is mounted to the mount. More specifically, the notch 11918 mayhelp take up interference forces that may occur as the sensor 11900 ismounted within the mount.

FIGS. 120A and 120B are isometric and partially exploded isometric viewsof an example connector assembly 12000, according to one or moreembodiments. As illustrated, the connector assembly 12000 may include aconnector 12002, and FIG. 120C is an isometric bottom view of theconnector 12002. The connector 12002 may comprise an injection moldedpart used to help secure one or more compliant carbon impregnatedpolymer modules 12004 (four shown in FIG. 120B) to a mount 12006. Morespecifically, the connector 12002 may help secure the modules 12004 inplace adjacent the sensor 11900 and in contact with the sensor contacts11914 (FIG. 119) provided on the flag 11904 (FIG. 119). The modules12004 may be made of a conductive material to provide conductivecommunication between the sensor 11900 and corresponding circuitrycontacts (not shown) provided within the mount 12006.

As best seen in FIG. 120C, the connector 12002 may define pockets 12008sized to receive the modules 12004. Moreover, in some embodiments, theconnector 12002 may further define one or more depressions 12010configured to mate with one or more corresponding flanges 12012 (FIG.120B) on the mount 12006. Mating the depressions 12010 with the flanges12012 may secure the connector 12002 to the mount 12006 via aninterference fit or the like. In other embodiments, the connector 12002may be secured to the mount 12006 using an adhesive or via sonicwelding.

FIGS. 121A and 121B are isometric and partially exploded isometric viewsof another example connector assembly 12100, according to one or moreembodiments. As illustrated, the connector assembly 12100 may include aconnector 12102, and FIG. 121C is an isometric bottom view of theconnector 12102. The connector 12102 may comprise an injection moldedpart used to help keep one or more compliant metal contacts 12104 (fourshown in FIG. 121B) secured against the sensor 11900 on a mount 12106.More specifically, the connector 12102 may help secure the contacts12104 in place adjacent the sensor 11900 and in contact with the sensorcontacts 11914 (FIG. 119) provided on the flag 11904. The contacts 12104may be made of a stamped conductive material that provides conductivecommunication between the sensor 11900 and corresponding circuitrycontacts (not shown) provided within the mount 12106. In someembodiments, for example, the contacts 12104 may be soldered to a PCB(not shown) arranged within the mount 12106.

As best seen in FIG. 121C, the connector 12102 may define pockets 12108sized to receive the contacts 12104. Moreover, in some embodiments, theconnector 12102 may further define one or more depressions 12110configured to mate with one or more corresponding flanges 12112 (FIG.120B) on the mount 12006. Mating the depressions 12110 with the flanges12112 may help secure the connector 12102 to the mount 12106 via aninterference fit or the like. In other embodiments, the connector 12102may be secured to the mount 12106 using an adhesive or via sonicwelding.

Therefore, the disclosed systems and methods are well adapted to attainthe ends and advantages mentioned as well as those that are inherenttherein. The particular embodiments disclosed above are illustrativeonly, as the teachings of the present disclosure may be modified andpracticed in different but equivalent manners apparent to those skilledin the art having the benefit of the teachings herein. Furthermore, nolimitations are intended to the details of construction or design hereinshown, other than as described in the claims below. It is thereforeevident that the particular illustrative embodiments disclosed above maybe altered, combined, or modified and all such variations are consideredwithin the scope of the present disclosure. The systems and methodsillustratively disclosed herein may suitably be practiced in the absenceof any element that is not specifically disclosed herein and/or anyoptional element disclosed herein. While compositions and methods aredescribed in terms of “comprising,” “containing,” or “including” variouscomponents or steps, the compositions and methods can also “consistessentially of” or “consist of” the various components and steps. Allnumbers and ranges disclosed above may vary by some amount. Whenever anumerical range with a lower limit and an upper limit is disclosed, anynumber and any included range falling within the range is specificallydisclosed. In particular, every range of values (of the form, “fromabout a to about b,” or, equivalently, “from approximately a to b,” or,equivalently, “from approximately a-b”) disclosed herein is to beunderstood to set forth every number and range encompassed within thebroader range of values. Also, the terms in the claims have their plain,ordinary meaning unless otherwise explicitly and clearly defined by thepatentee. Moreover, the indefinite articles “a” or “an,” as used in theclaims, are defined herein to mean one or more than one of the elementsthat it introduces. If there is any conflict in the usages of a word orterm in this specification and one or more patent or other documentsthat may be incorporated herein by reference, the definitions that areconsistent with this specification should be adopted.

As used herein, the phrase “at least one of” preceding a series ofitems, with the terms “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” allows a meaning that includesat least one of any one of the items, and/or at least one of anycombination of the items, and/or at least one of each of the items. Byway of example, the phrases “at least one of A, B, and C” or “at leastone of A, B, or C” each refer to only A, only B, or only C; anycombination of A, B, and C; and/or at least one of each of A, B, and C.

The use of directional terms such as above, below, upper, lower, upward,downward, left, and right and the like are used in relation to theillustrative embodiments as they are depicted in the figures, the upwarddirection being toward the top of the corresponding figure and thedownward direction being toward the bottom of the corresponding figure.

What is claimed is:
 1. An assembly for delivery of a glucose sensorcomprising: a sensor control device including: an electronics housingcomprising: a shell having an upper surface with a first aperturedefined in the upper surface at a first location and a depressiondefined in the upper surface at a second location spaced apart from thefirst location, and a mount mated to the shell and having an undersidewith a second aperture defined therein being aligned with the firstaperture; a circuit board disposed within the electronics housing andincluding a plurality of electronics modules; a glucose sensorelectrically coupled with the circuit board and configured to measure aglucose level; an adhesive patch attached to the underside of the mountand configured to secure the sensor control device on the user's skin;and an applicator comprising: an applicator housing; a sheath coupled tothe applicator housing and configured to engage the user's skin at atarget monitoring location; a sharp carrier coupled to a sharp extendingthrough the first aperture and the second aperture, the sharp configuredto penetrate the user's skin to position the distal portion of theglucose sensor into contact with bodily fluid of the user; an applicatorcap having a distal end having one or more vents defined therein and aproximal end removably coupled to a distal end of the applicatorhousing; a seal to occlude the one or more vents on the distal end ofthe applicator cap, wherein the applicator cap, the applicator housing,and the seal define an interior space with the sensor control device,the sheath, the sharp carrier, and the sharp disposed therein, whereinthe interior space includes a sterilization chamber with the electronicshousing, the circuit board, the adhesive patch, the sheath, and thesharp carrier exposed in the sterilization chamber, and wherein the oneor more vents are configured to allow injection of a sterilizing gasinto the sterilization chamber.
 2. The assembly of claim 1, wherein thedistal end of the applicator cap includes a recessed platform, whereinthe one or more vents are defined in the recessed platform.
 3. Theassembly of claim 2, wherein the seal is disposed on the recessedplatform.
 4. The assembly of claim 1, wherein the one or more ventscomprises two vents.
 5. The assembly of claim 1, wherein the seal isgas-permeable.
 6. The assembly of claim 5, wherein the seal includes aTyvek material.
 7. The assembly of claim 5, wherein the seal protectsthe sterilization chamber against moisture and harmful elements.
 8. Theassembly of claim 1, wherein the seal comprises two or more layers. 9.The assembly of claim 8, wherein a first layer of the seal isgas-permeable and a second layer of the seal is vapor and moistureresistant material.
 10. The assembly of claim 9, wherein the secondlayer is configured to prevent ingress of contaminants into thesterilization chamber.
 11. The assembly of claim 1, wherein thesterilizing gas includes ethylene oxide.
 12. The assembly of claim 1,wherein the applicator further comprises a sealing gasket configured toseal an interface between the applicator housing and the applicator cap.13. The assembly of claim 1, wherein the applicator further comprises aspring biasing the sharp carrier to move towards a proximal end of theapplicator housing.
 14. The assembly of claim 1, wherein the proximalend of the applicator cap is removably coupled to the distal end of theapplicator housing during factory assembly.
 15. The assembly of claim 1,wherein the proximal end of the applicator cap is removably coupled tothe distal end of the applicator housing via a threading engagement. 16.The assembly of claim 1, wherein the first and second locations arespaced apart from a center of the electronics housing.
 17. The assemblyof claim 1, wherein the distal portion of the applicator cap includes aplurality of integrally formed grip features.
 18. The assembly of claim1, wherein the sheath is collapsible to allow the sensor control deviceto advance into engagement with the user's skin.
 19. The assembly ofclaim 1, wherein the sharp carrier and the sharp are configured to beautomatically retracted after the applicator housing is advanced towardsthe target monitoring location.
 20. The assembly of claim 1, wherein theshell defines at least one of a chamfered or angled outer periphery. 21.The assembly of claim 1, wherein the circuit board includes a thirdaperture aligned with the first aperture and the second aperture. 22.The assembly of claim 1, further comprising an adhesive to secure theshell to the mount.
 23. The assembly of claim 22, wherein the adhesiveisolates an interior of the electronics housing from outsidecontamination.
 24. The assembly of claim 1, wherein the shell is securedto the mount via snap fit engagement, an interference fit, sonicwelding, ultrasonic welding, or mechanical fasteners.
 25. The assemblyof claim 1, wherein the mount further comprises a plurality of modulepockets to partially accommodate the plurality of electronics modules.26. The assembly of claim 1, further comprising a plurality of discretegrooves defined at an outer periphery of the mount.
 27. The assembly ofclaim 26, wherein the plurality of discrete grooves are on the undersideof the mount and extend into a sidewall of the mount.
 28. The assemblyof claim 27, wherein the plurality of discrete grooves do notinterconnect on the underside of the mount.
 29. The assembly of claim26, wherein the plurality of discrete grooves are symmetrically arrangedon the underside of the mount.